AN OBSERVATIONAL STUDY ON ASSESSMENT OF POSTOPERATIVE COMPLICATIONS AMONG PERFORATION PERITONITIS USING CLAVIEN-DINDO CLASSIFICATION IN TERTIARY CARE CENTRAL INDIA

Our study reveals that 50(83.33%) patients had single perforation out of which 33 (66%) patients were haemodynamically stable and 17(34%) patients were unstable ,complication occurred in 35 (70%) patients and no complication found in 15(30%).In this group 42(84%) patients got discharged and 8(16%) patient expired. Chi Square Value was 4.57 and P Value was<0.102 which is not significant. is expired and absent in out which 69(92%) is recoverd and 6(8.1%). Statistical test is chi-square test and p-value 0.001, which shows that comorbid conditions like diabetes, hypertension, COPD and renal failure increase mortality. test „t‟ and perforations were found out of which only 01 (10%) patient is haemodynamically stable and 09 (90%) patients were unstable,complication occurred in 09(90%) patients and no complication were only in 01(10%) patients. In this group 04(40%) patients got discharged and 6(60%) patient expired. Rao R et al. (2016) [33] study shows that there is single perforation in 79% patient, two perforation in 4% patient and multiple perforation in 17% patient. Manikanta K S et al. (2016) [28] study shows that Single perforations were observed in 33(66%) patients, two perforations were found in 7(14%) patients, three perforations in 6(12%) patients, whereas four perforations were seen in 4(8%) patients. classification clavien-dindo classification of


ISSN: 2320-5407
Int. J. Adv. Res. 9(02), 922-937 923 patients and no complication were only in 01 (10%) patients. In this group 04(40%) patients got discharged and 6(60%) patient expired. P Value was 0.001 which is significant. In our study most common site of perforation was gastric perforation 30(49.18%) Complication according to clavien -dindo classification 14 out of 60 (23.33%) patients had no complications, 4 (6.66%) had grade I complication, 5 (8.33%) had grade II complications, 12 (20%) had grade III complications, 11 (18.33%) had grade IV complications, and 14 (23.33%) had grade V complication rates. Conclusion :Perforation peritonitis is a life-threatening condition and requires urgent hospital care, resuscitation and surgery. Early resuscitation and surgery are required to decrease morbidity and mortality. On the basis of risk stratification in Peritonitis patients its management requires lots of expensive modalities, skill, monitoring and treatment to provide better care to the patient. For the classification of complications, a new system is proposed by Clavien-Dindo which is very helpful during perforation surgery.Clavien-Dindo classification helps us to distinguish a normal postoperative course and the severity of complications, which allows us to compare postoperative morbidity and evaluate the outcomes. We also recommend a larger study with a bigger sample size for better analysis of clavien-dindo classification of complications and to confirm the findings of our study.

…………………………………………………………………………………………………….... Introduction:-
Perforation peritonitis is one of the most common surgical emergencies across the globe. Gastrointestinal perforations have very high morbidity and mortality rates, irrespective of the type of operative procedure performed. The Clavien-Dindo system is nowadays widely used for complications after surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures and has become the standard classification system for many surgical specialties for open as well as laparoscopic surgeries. Complications are now used as a basis to evaluate the improvement in standard surgical procedures, for selection of management options, and to compare results in individual centers and among centers. [1] When a new surgical procedure is introduced or when several surgical approaches exists for one procedure, there is a need to compare outcomes and complication for each specific approach in a sound and reproducible way. [2][3][4][5] Clavien-Dindo (CD) classification is the simplest way of reporting all complications. [5][6][7] It allows surgeons to distinguish between a normal postoperative course from any deviation and the severity of the complication and it may be useful for comparing postoperative morbidity in each patients. [6,[8][9][10][11] A classification is useful only if it is widely accepted and applied throughout different countries and surgical cultures. [12][13][14][15][16] Morbidity was defined as all the non-fatal surgical and/or medical complications occurred during the patient"s stay in hospital, in the 30-day period following the operation. [10,11,17,18] The main aim of this study was to test the usefulness of Clavien-Dindo classification in patients undergoing the abdominal surgery. In this study ClavienDindo classification has been used for assessment of postsurgical complications after major abdominal surgery. Emergency surgical patients are an important target group for quality improvement, and negative outcomes should be measured and classified in order to find more specific targets for quality improvement. [19][20][21][22][23] Hence, assessments of complications in emergency abdominal surgeries were also included in the study along with elective abdominal surgeries. Thereby improving management and prevention. The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) 924 Table 1:-Classification of surgical complications as per the classification proposed by Clavien-Dindo et al.
The Clavien-Dindo system allows us to 1) Evaluate the quality of procedures and outcomes from a particular procedure 2) Compare different approaches or procedures as well as helps in comparison between surgeons, and health institutions 3) Analyze and records learning curves of surgical techniques. 4) Use it as the basis of improve quality of care and procedures 5) To standardize and measure surgical errors. 6) To accurately explain and compare different procedures to their patients in terms of risks and complications

Material and Method:-
It was an observational study of all perforation peritonitis patients admitted in SRI AUROBINDO MEDICAL COLLEGE AND POST GRADUATE INSTITUTE between NOVEMBER 2017 to MAY 2019(1 and 1/2 Year) on the basis of Clavien-Dindo classification.

Inclusion criteria:
Patients who are willing for study.All the patients both male and female in the age group more than 10 years with peritonitis caused by perforation of the gastrointestinal tracts were included in this study.

Exclusion criteria:
Patients who are not willing for study. All the patients of primary peritonitis, corrosive, postoperative peritonitis caused by anastomosis leakage. All the patients of primary peritonitis, corrosive, postoperative peritonitis caused by anastomosis leakage. Children below than 10 years. were excluded from the study.

Selection of cases:
An informed written conset was taken from all the patients / relatives in groups after the approval of institutional ethic committee.

Sample:
We expected 60 or more patients of perforation peritonitis undergoinglaparotomy in this study period of one and half year. We have reached this figure after scrutinizing the past records, which suggest that every month five to six patients are operated in our Institute. It is an observational study.Data collection from patients by their clinical history, examination, with appropriate investigations. The cases were evaluated by history, clinical features and special tests if any required.

Method of data collection:
From cases attending our institute in which diagnosis of peritonitis is established by operative findings or surgical interventions during management. Therefore, nonrandomized sampling technique was used.Pre designed semi structure questions were used.  13 were male and 02 were female, comorbidities were present in 08(53.33%) and absent in 7(46.66%) patients. 10(66.66%) patients were discharged in this group and 5(33.33%) patients expired, Next age group of 60 or more years comprising of 8 patients out of which 1 was male and 07 were female, comorbid conditions were present in 02(25%) and absent in 6(75%) patients. all the 8 (100%)patients in this group discharged.  Patients who presented after 3 days from onset of symptoms 20 (33.33%) all of them had complications20(100%). However out of 20 patients In this group 7 patients got discharged 7(35%) and 13 patients expired.Chi Square Value was 19.33 and P Value was<0.001 which is significant.Above table 4 and graphs shows that Patients presenting within 1 day or less from the onset of symptoms were 4 (6.66%) out of which all 4(100%) patients had size of perforation 1*1cm or less& .In this group all 04(100%) patients were haemodynamically stable. All the 4 patients in this group got discharged.ChiSquare Value was 11.1 and P Value was 0.011 which is significant.  In the present study out of the sample of 60 cases in majority of the cases free gas under diaphragm was seen i.e. in 51 cases. Accounting for 85% was seen in X-Ray Erect abdomen and Chest X-ray PA view.  --CT is done in 11 patients in whom X-ray and USG whole abdomen was inconclusive in all 11 (100 %) patient"s positive findings were present in computed tomography in the form of pneumoperitoneum with fluid.  Table-9 and Graphs shows that in those 16 (26.6%) patients whom comorbid condition present 4 (25%) patient presented with in 2-3 days , 12 (75%)presented after 3 days and none of them presented within 1 days of onset of symptom ,the haemodynamically stable were 04 (25%) patients and unstable were 12 (75%)patients . In this group 07(43.75%) patients got discharged and 9(56.25%) patient expired.Chi Square Value was 1.75 and P Value was 0.418 which is not significant.

01(100%) NA
One patient had both gastric and ileal perforation therefore n=61 in above observation table  were present, out of them 12(75%) patients presented after 3 days of onset of symptoms. 12 (75%) patients were haemodynamically unstable. In this group 07(43.75%) patients got discharged and 9(56.25%) patient expired. In the present study in majority of the cases free gas under diaphragm was seen i.e. in 51 cases. accounting for 85% was seen in X-Ray Erect abdomen and Chest X-ray PA view. This still remains important diagnostic imaging. In 29 (48.33%) patient size of perforation was more than 1 cm out of which in 10(32.25%) patients comorbid condition were present, absent in 19 (65.51%) patient, complication observed in 28(96.55%) patient and in only 01 (3.44%) patient there was no complication. P Value was <0.001 which is significant. In 10 (16.66%) patients multiple perforations were found out of which only 01 (10%) patient is haemodynamically stable and 09 (90%) patients were unstable. Complication occurred in 09(90%) patients and no complication were only in 01 (10%) patients. In this group 04(40%) patients got discharged and 6(60%) patient expired. P Value was 0.001 which is significant.In 24(40%) patients more than 500 ml intraperitoneal collection was found, out of which complications developed in all 24(100%) patients, haemodynamicunstability was present in 18(75%) patients,duration of hospital stay was more than 14 days in 14(58.33%) patients. In this group11(45.83%) patients got discharged and 13(54.16%) patients expired. Chi Square Value was 42.8 and P Value was<0.001 which is significant.In our study most common site of perforation was gastric perforation 30(49.18%) out of which11 (36 %) patients were managed by grahm"s patch repair, 5 (45%) patient had better outcome and 6 (54%) patient had worse outcome. modified grahm"s patch repair in 19 (64%), 8 (42%) patient had better outcome and 11 (57.89%) patient had worse outcome.Next major group was ileal perforation 23(37.7%) was managed by primary repair 15 ( %) , 6 (40%) patient had better outcome and 9 (60%) patient had worse outcome. Ileostomy with or without primary repair done in 03 (%), all 3(100%) had worse outcome and resection and anastomosis done in 05() patients 2 (40%) had better outcome and 3 (60%) patients had worse outcome.P valve is significant for gastric and ileal perforation.Most common procedure performed was exploratory laparotomy with modified grahm"s omental patch repair in 19 (

Discussion:-
Perforation peritonitis is one of the most common surgical emergencies across the globe.Gastrointestinal perforations have very high morbidity and mortality rates, irrespective of the type of operative procedure performed. The aim of the present study is to assess thecomplications and factors responsible for outcomes in cases ofgastrointestinal perforations in tertiary care centre and also, to find out various determinants for safe outcomes in gastrointestinal perforation in terms of decreased morbidity and mortality and applying Clavien-Dindoclassification for postoperative complications for evaluating the outcome.Despite of modern treatment, complications are very common in cases of perforated gastrointestinal tract, even at centers with best facilities,in this study, an attempt is made to find out various preoperative and intra operative factors that may responsible for adverse outcome and to identify the best management that could decrease the complication rate.  [24] study shows that Maximum patients were in the age group of20-39 year has 47 patient out of which 46(98%) patients recovered and 1(2%) patient expired, followed by age group 40-59 year has 28 patients out of which 20(71.5%) patients recovered and 8(28.5%) patient expired, Next age group of more than 60 year comprising of 21 patient out of which 15(71.5%) patients recovered and 6 (28.5%)patient expired. The age group 20 year or less has 4 patient only out of which 4(100%) all patients are recovered and discharge.   [25] study shows that the patients varied from 19 to 60 years with most of the patients falling within the age range of 21-30 years. Their mean age was 34.42 years. The majority of patients were male (77.6% male vs. 22.4% female).

Time Of Presentation:-
In our study Majority of patients presented within 2-3 days from the onset of symptoms 36(60%)out of which complications occured in 23(63.88%) patients and recovery without complication in 13(36.11%) patients. In this group 35(97.22%) patients got discharged and 1(2.77%) patient expired, P Value was<0.001 which is significant.Next group was of patients who presented after 3 days from onset of symptoms 20 (33.33%)all of them had complications 20(100%). However out of 20 patients. In this group 7 patient got discharged 7(35%) and 13 (65%) patients expired P Value was<0.001 which is significant.Smallest group was of Patients presenting within 1 day or less from the onset of symptoms were 4 (6.66%) out of which complications occurred in 1 (25%) patient rest 3(75%) had normal recovery. All the 4 patients in this group got discharged P Value was 0.028 which is significant. Abdulhameed MME, et al. (2016) [24] -Out of 100 patients time of presentation 1 day or less is 29(29%) patients out of which 29(100%) is recovered and 0(0%) is expired,2-3 days 55(55%) patients out of which 49(89%) is recovered and 6(11%) is expired and more than 3 days 16(16%) patients out of which 6(37.5%) is recovered and 10(62.5%) is expired. Mean Time of presentation 2.27 days and standard deviation is 1.12. Recovered 84 (84%) patient and death 16 patient. Statistical test is "t" test and p value are< 0.001 implies mortality increases with delayed presentation.Jobta R, et al. (2006) [26] study shows that the time taken by the patient between onset of symptoms and presentation to the hospital was less than 24 hours in 235(47%) cases and more than 24 hours in 269(53%) cases.  [27] study shows that there isabdominal pain in 99% patient, nausea in 92% patient, vomiting in 55% patient, abdominal distension in 71% patient, fever in 64% patient, altered bowel habit in 42% patient and shock in 12% patient.   [25] study shows that there is abdominal pain in 97.3% patient, abdominal distension in 75% patient, altered bowel habit in 56.6% patient, nausea or vomiting in 52.6% patient, fever in 34% patient, and shock in 30% patient due to septicaemia.

Free gas under Diaphragm:
In the present study out of the sample of 60 cases in majority of the cases free gas under diaphragm was seen i.e. in 51 cases. accounting for 85% was seen in X-Ray Erect abdomen and Chest X-ray PA view. This still remains important diagnostic imaging in 09 (15 %) patients absence of gas might be in cases of distal perforation.Singh SK, et al. (2019) [29] study shows that presence of free air under diaphragm in 62.67 % of patients.

Comorbid Condition:
In our study comorbidities were absent in 44(73.33%) patient in those 32 (72.7%) presented with in 2-3 days , 08 (18.18%)presented after 3 days and 4 (9.09%) patient presented within 1 days of onset of symptom ,of these the haemodynamically stable were 30 (68.18%) patients and unstable were 14 (31.81%) patients. In this group 39(88.63%) patients got discharged and 5(11.36%) patient expired. and P Value was 0.020 which is significant.[ for comorbid condition,haemodynamically condition &outcome]. In those whom comorbid condition present 16 (26.6%) patients in those 4 (25%) patient presented with in 2-3 days, 12 (75%)presented after 3 days and none of them presented within 1 days of onset of symptom, the haemodynamically stable were 04 (25%) patients and unstable were 12 (75%)patients. In this group 07(43.75%) patients got discharged and 9(56.25%) patient expired. Chi Square Value was 1.75 and P Value was 0.418 which is not significant[increase in haemodynamicallyunstability and mortality in presence of comorbid condition].Abdulhameed MME, et al. (2016) [24] study shows thatComorbid condition present in 25 patient out of which 15 (60%) patient is recoverd and 10 (40%) is expired and absent in 75 out of which 69(92%) patient is recoverd and 6(8.1%). Statistical test is chi-square test and p-value 0.001, which shows that comorbid conditions like diabetes, hypertension, COPD and renal failure increase mortality.

Haemodynamic Condition:
Majority of patients presented within 2-3 days from the onset of symptoms 36(60%) out of which in 26(72.22%) patients size of perforation was 1cm or less and in 10 (27.77%) patient it was more than 1*1cm.In this group haemodynamically stable patient were 27(75%)and haemodynamically unstable were 09 (25%) patients.out of total patients in group 35(97.22%) patients got discharged and 1(2.77%) patient expired. Chi Square Value was 12.4 and P Value was0.006 which is significant.
Next group of patients who presented after 3 days from onset of symptoms 20(33.33%), out of which in 08(40%) of them size of perforation was 1cm or less& in 12 (60%) more than 1*1cm size.In this group haemodynamically stable patient were 03(15%)and haemodynamically unstable were 17 (85%) patients.out of total patients In this group 7 patients got discharged 7(35%) and 13 patient expired. Chi Square Value was 19.33 and P Value was<0.001 which is significant. Paryani JJ, et al. (2013) [73] found that mortality rate was 80% for patients with blood pressure <100 mmHg. Kamble R S, et al. (2016) [31] study shows that 7.69% of the cases with heart rate <100/min died which was significantly less as compared to 25% of cases with heart rate>/=100/min, but difference was not statistically significant and 29.17% of the cases with heart rate <100/min had hospital stay >10 days which was less as compared to 61.11% of cases with >/=100 heart rate, and the difference was statistically significant.  [24] study shows that Size of perforation Up to 1 cm in 77 patient (77%) out of which 71 (92%) patient recovered and 6(8%)patient expired and size of perforation is more than 1 cm in 23 patient out of which 15(65%) patient recovered and 8(35%) patient expired. Mean size of perforation is 1.29 cm and standard deviation is .518. Statistical test is "t" test and p value are 0.001 implies size of perforation influence outcome. Gupta Set al. (2010) [32] study shows that Size of perforation is between 0-<0.5 cm in 293 patient, 0.5-<1cm in 57 patient, 1-<2 cm in 35 patient and more than 2 cm in 15 patients.

Intraperitoneal Collection:
In our study intraperitoneal collection upto 500 ml is found in 36(60%) patient out of the group complication developed in 20(55.55%)patient and no complication seen in 16 [31] Out of 50 patients 16 patients had >/= 1000 ml of contamination out of which 5 died which was more than the patients died of having <1000 ml contamination. There result reveals that, 8.8% of cases with <1000 ml of contamination died which was significantly less as compared to 31.2% of cases with >/=1000 ml, and the difference is statistically significant and 29.0% of the cases with <1000 ml contamination had >10 days hospital stay which was significantly less as compared to 81.8% of cases with >/=1000 ml and the difference is statistically significant.

Conclusion:-
Perforation peritonitis is a life-threatening condition and requires urgent hospital care, resuscitation and surgery. Early resuscitation and surgery are required to decrease morbidity and mortality. Management and outcomes of perforation peritonitis depends on various factors such as perioperative and intra operative condition.Post-operative complications increases due to comorbid conditions, size and number of perforations and it also affects the outcome of the patient. It is observed that with the increase in contamination (intraperitoneal collection) morbidity increases.On the basis of risk stratification in Peritonitis patients its management requires lots of expensive modalities, skill, monitoring and treatment to provide better care to the patient.For the classification of complications, a new system is proposed by Clavien-Dindo which is very helpful during perforation surgery, it is used in all over the world and facilitates in comparisons or evaluation of various surgical outcomes between different centres , therapies or surgeons. Clavien-Dindo classification helps us to distinguish a normal postoperative course and the severity of complications, which allows us to compare postoperative morbidity and evaluate the outcomes. The new classification mainly focuses on the medical perspective, with a major emphasis on the risk, type of anaesthesiaand procedures or therapy used to correct a complication.We therefore recommend the use of claviendindo classification of complications. We also recommend a larger study with a bigger sample size for better analysis of clavien-dindo classification of complications and to confirm the findings of our study.