Identifying and costing common gaps in Central and West Africa pharmaceutical regulation.

Background: Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrumental for the newly incepted African Medicine Agency. Aims: This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally. Objectives: The study used NRA self-assessment outcomes to identify common gaps in four critical regulatory pillars and estimate the cost of addressing them from regional perspectives that aimed at raising the maturity level of regulatory institutions. Methods: A cross-sectional study, using the WHO Global Benchmarking Tool (GBT), was conducted between 2020 and 2021 with five NRAs from ECCAS and ECOWAS member states that use French and Spanish as lingua franca. Results: The 10 NRAs operated in a non-formal-to-reactive approach (ML1-2), which hinders their ability to ensure the quality of MPHT and respond appropriately to public health emergencies. Common gaps were identified in four critical regulatory pillars-good regulatory practices, preparedness for public health emergencies, quality management systems, and substandard and falsified medical products-with overall cost to address gaps estimated at US$3.3 million. Contribution: We elaborated a reproducible method to strengthen regulatory systems at a regional level to improve equitable access to assured-quality MPHT. Our bottom-up approach could be utilized by RECs to address common gaps through common efforts.

Pyridazine and pyridazinone derivatives: Synthesis and in vitro investigation of their anti-inflammatory potential in LPS-induced RAW264.7 macrophages.

New pyridazine and pyridazinone derivatives 3a-g, 4a-f, 6a, and 6b were designed and synthesized. Cell viability of all compounds was established based on the viability of lipopolysaccharide-induced RAW264.7 macrophage cells determined via the MTT assay. In vitro inhibition assays on human COX-1 and COX-2 enzymes were conducted to probe the newly synthesized compounds' anti-inflammatory activity. The half maximal inhibitory concentration values for the most active compounds, 3d, 3e, and 4e towards COX-2 were 0.425, 0.519, and 0.356 µM, respectively, in comparison with celecoxib. The newly synthesized compounds' ability to inhibit the production of certain proinflammatory cytokines, such as inducible nitric oxide synthase, tumor necrosis factor-α, interleukin-6, and prostaglandin-E2, was also estimated in lipopolysaccharide-induced macrophages (RAW264.7 cells). Compounds 3d and 3e were identified as the most potent cytokine production inhibitors. The results of molecular modeling studies suggested that these compounds were characterized by a reasonable binding affinity toward the active site of COX-2, when compared to a reference ligand. These results might be taken into consideration in further investigations into new anti-inflammatory agents.

Predictors for local recurrence and distant metastasis of mucinous colorectal adenocarcinoma.

BACKGROUND: Mucinous adenocarcinoma (MA) is a unique subtype of colorectal carcinoma. Although some investigators considered MA a predictor for poor prognosis, predictors for poor clinical outcome of MA were not elucidated. The present study aimed to investigate the predictors for local recurrence and distant metastasis of MA. METHODS: This was a retrospective review of patients with MA who underwent operation with curative intent. Variables included patient and tumor characteristics, TNM stage, investigations, details of surgery, and postoperative outcomes, including local recurrence and distant metastasis. Univariate and multivariate regression analyses were performed to determine the risk factors for local and systemic disease recurrence. RESULTS: A total of 106 patients (83 male) of a mean age of 51.5 years were included; 62% of patients had colonic tumors, and 38% had rectal tumors; 77% and 58% of colonic and rectal cancers, respectively, were T3-T4 tumors. There were no lymph node metastases in 61% of colonic tumors and 55% of rectal tumors. Local recurrence occurred in 15 patients (14%) and distant metastasis in 9 (9%). Predictors for local recurrence were age (odds ratio [OR]: 1.04; P = .04), female sex (OR: 4.5; P = .01), rectal tumors (OR: 3.73; P = .02), and T4 tumors (OR: 10.9; P = 0.03). Predictors for distant metastasis were age (OR: 1.1; P = .016), local recurrence (OR: 24.28; P < .0001), and T4 tumors (OR: 19.3; P = .049). CONCLUSION: Patients' age, female sex, and T4 tumors were significant predictors for local recurrence and distant metastasis. Rectal tumors had a greater likelihood for regional recurrence than colonic tumors. Local recurrence was an independent risk factor for distant metastasis.

Utility of Endoanal Ultrasonography in Assessment of Primary and Recurrent Anal Fistulas and for Detection of Associated Anal Sphincter Defects.

BACKGROUND: Tridimensional endoanal ultrasonography (3D-EAUS) has been used for the assessment of various anorectal lesions. Previous studies have reported good accuracy of 3D-EAUS in preoperative assessment of fistula-in-ano (FIA). This study aimed to assess the diagnostic utility of 3D-EAUS in preoperative evaluation of primary and recurrent FIA and its role in detection of associated anal sphincter (AS) defects. PATIENTS AND METHODS: Prospectively collected data of patients with FIA who were investigated with 3D-EAUS were reviewed. The findings of EAUS were compared with the intraoperative findings, the reference standard, to find the degree of agreement regarding the position of the internal opening (IO) and primary tract (PT), and presence of secondary tracts using kappa (k) coefficient test. A subgroup analysis was performed to compare the accuracy and sensitivity of EAUS for primary and recurrent FIA. RESULTS: Of the patients, 131 were included to the study. EAUS had an overall accuracy of 87, 88.5, and 89.5% in detection of IO, PT, and AS defects, respectively. There was very good concordance between the findings of EAUS and intraoperative findings for the investigated parameters (kappa = 0.748, 0.83, 0.935), respectively. Accuracy and sensitivity of EAUS in recurrent FIA were insignificantly lower than primary cases. EAUS detected occult AS defects in 5.3% of the patients studied. CONCLUSION: The diagnostic utility of 3D-EAUS was comparable in primary and recurrent FIA. 3D-EAUS was able to detect symptomatic and occult AS defects with higher accuracy than clinical examination.

Outcomes following repair of incarcerated and strangulated ventral hernias with or without synthetic mesh.

BACKGROUND: The use of synthetic mesh for ventral hernia repair under contaminated conditions is a controversial issue due to the considerable risk of surgical site infection (SSI). This study aimed to review the outcomes of repair of incarcerated and strangulated ventral hernias with or without synthetic mesh in compliance with established clinical guidelines regarding the incidence of SSI and hernia recurrence. METHODS: The records of patients with complicated ventral hernias who were treated with or without synthetic mesh repair were reviewed. Variables collected included the characteristics of patients and of ventral hernias, type of repair, and incidence of SSI and recurrence. RESULTS: One hundred twenty-two patients (56 males) of a mean age of 56 years were included. Fifty-two (42.6%) and 70 (57.4%) patients presented with incarcerated and strangulated ventral hernias, respectively. Sixty-six (54%) patients were treated with on-lay mesh repair, and 56 (46%) were managed with suture repair. Twenty-one patients required bowel resection. SSI was detected in eight (6.5%) patients. There was no significant difference between both groups regarding the incidence of SSI (7.5% for mesh group vs 5.3% for suture group). Recurrence occurred in seven patients. Median follow-up period was 24 months. The suture repair group had a significantly higher incidence of recurrence than the mesh group. Diabetes mellitus, previous recurrence, and intestinal resection were significant predictors for SSI. CONCLUSION: Following established guidelines, synthetic mesh repair of incarcerated and strangulated ventral hernias attained lower recurrence rate, comparable incidence of SSI, and higher rate of seroma formation than suture repair. TRIAL REGISTRATION: Research Registry, researchregistry1891.

Does the duration of symptoms of anal fissure impact its response to conservative treatment? A prospective cohort study.

BACKGROUND: Conservative treatment is the first line of treatment for anal fissure. The current study aimed to evaluate the impact of symptom duration on the response of anal fissure to conservative treatment. PATIENTS AND METHODS: This prospective study was conducted on sixty patients with acute or chronic anal fissure who were treated conservatively with bulking agents, Sitz baths, and topical glyceryl trinitrate (GTN) 0.2%. Pain and constipation were assessed prior to treatment and at 6 weeks after therapy using visual analogue scale (VAS) and Wexner constipation score. Adverse effects as headache and postural hypotension were also queried. RESULTS: The mean pre-treatment VAS for acute fissure was significantly higher than chronic fissure (8.8 ± 0.96 Vs 5.8 ± 1.12), also the post-treatment VAS for acute fissure was significantly lower at 6 weeks of treatment (0.47 ± 0.8 Vs 2.5 ± 1.3). The baseline Wexner constipation score was comparable in both groups; however, at six weeks of treatment it declined more significantly in patients with acute fissure. Patients with acute fissure achieved significantly better healing than chronic fissure (80% Vs 40%). Healing rates decreased from 100% in patients with symptoms < one month to 33.3% in patients with symptoms >6 months. CONCLUSION: Conservative treatment including topical GTN 0.2% significantly hastened healing and relieved pain and other symptoms of acute more than chronic anal fissure. Healing rates of anal fissure in response to conservative treatment showed remarkable decrease in proportion to the duration of complaint.

Predictive factors for recurrence of high transsphincteric anal fistula after placement of seton.

BACKGROUND: The optimal surgical treatment for high transsphincteric fistula-in-ano (FIA) should attain complete eradication of the fistulous track and, in the same time, not compromising the anal sphincters. The present study aimed to investigate the predictive factors for recurrence of high transsphincteric FIA after placement of draining seton and to evaluate the efficacy and complications of seton treatment for high cryptoglandular anal fistula. MATERIALS AND METHODS: This is a retrospective case-control study of patients with high transsphincteric FIA who were treated with seton placement. Variables analyzed were the characteristics of FIA, incidence of recurrence, postoperative complications including fecal incontinence (FI), and the predictive factors for recurrence. RESULTS: A total of 251 patients (232 males) with high transsphincteric FIA were treated with loose seton placement. Patients were followed for a median period of 16 mo. Recurrence of FIA was recorded in 26 of patients (10.3%) after a mean duration of 12.2 ± 3.9 mo of seton removal. Previously recurrent fistula (odds ratio [OR] = 2.81, P = 0.02), supralevator extension (OR = 3.19, P = 0.01) and anterior fistula (OR = 3.36, P = 0.004), and horseshoe fistula (OR = 5.66, P = 0.009) were the most significant predictors of recurrence. FI was detected in eight patients (3.2%). Female gender (OR = 15.2, P = 0.0003) and horseshoe fistula (OR = 8.66, P = 0.01) were the significant risk factors for FI after the procedure. CONCLUSIONS: Significant risk factors for recurrence of FIA were previous fistula surgery, anterior anal fistula, and presence of secondary tracks or branches as supralevator extension, and horseshoe fistula.

Management Options for Twisted Gastric Tube after Laparoscopic Sleeve Gastrectomy.

PURPOSE: This study aims to determine the incidence, etiology, and management options for symptomatic gastric obstruction caused by axially twisted sleeve gastrectomy. METHODS: In this retrospective study, we reviewed medical charts of all morbidly obese patients who underwent laparoscopic sleeve gastrectomy. Patients who developed gastric obstruction symptoms and were diagnosed with twisted sleeve gastrectomy were identified and included in this study. RESULTS: From October 2005 to December 2015, there are 3634 morbidly obese patients who underwent laparoscopic sleeve gastrectomy (LSG). Eighty-six (2.3%) patients developed symptoms of gastric obstruction. Forty-five (1.23%) patients were included in this study. The mean time of presentation was 59.8 days after surgery. Upper GI contrast study was done routinely, and it was positive for axial twist in 37 (82%) patients. Abdominal CT with oral and IV contrast was done in eight (18%) when swallow study was equivocal. Endoscopic treatment was successful in 43 patients (95.5%). Sixteen patients were successfully managed by endoscopic stenting, and 29 patients had balloon dilation. The average numbers of dilation sessions were 1.7. Out of these 29 patients, 18 responded well to a single session of dilatation and did not require any further dilatation sessions. Two patients who failed to respond to three subsequent sessions of balloon dilation underwent laparoscopic adhesiolysis and gastropexy. CONCLUSIONS: Endoscopic stenting is an effective tool in management of axial rotation of sleeved stomach. Balloon dilation can also be effective in selected cases. Few cases might require laparoscopic adhesiolysis and gastropexy.

Preliminary experience with laparoscopic common bile duct exploration.

BACKGROUND: Herein we present our experience with laparoscopic common bile duct exploration (LCBDE) in managing common bile duct stones. METHODS: Data of 129 consecutive patients who underwent laparoscopic cholecystectomy (LC) and LCBDE done at our institutes from April 2011 through June 2016 were prospectively recorded and retrospectively reviewed. RESULTS: Since 2011, 3012 laparoscopic cholecystectomy were performed at our institutes, intraoperative cholangiogram (IOC) was done in 295 (9.8%) patients which detected choledocholithiasis in 129 (4.3%) of them. LCBDE was successful to clear the common bile duct (CBD) in 123/129 (95.4%). Six patients underwent postoperative endoscopic retrograde cholangiopancreatography (ERCP) because of incomplete CBD clearance (4 cases), symptomatic stenosed papilla (2 cases). LCBDE was performed in 103 patients via trans-cystic approach and choledochotomy one in 26 patients. In the choledochotomy group, seven patients had primary closure of the CBD, CBD was closed over T-tube in nine patients whereas the remaining 10 patients the CBD was closed over antegrade inserted stent. The median time of hospital stay was 4 (range; 1-15) days. No patients showed retained CBD stones with mean follow up was 9 ± 3.4 months. CONCLUSION: LCBDE is a safe and cost effective option for CBD stones in short-term outcome and can be performed provided proper laparoscopic expertise and facilities are available.

Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in the Treatment of Type I Anterior Rectocele: a Randomized Controlled Trial.

BACKGROUND AND AIM: Two types of rectocele exist; type I is characterized by relatively high resting anal pressures, whereas type II has lower resting anal pressures with associated pelvic organ prolapse. We compared trans-perineal repair (TPR) of rectocele with or without limited internal sphincterotomy (LIS) in the treatment of type I anterior rectocele. PATIENTS AND INTERVENTIONS: Consecutive patients with anterior rectocele were evaluated for inclusion. Sixty-two female patients with type I anterior rectocele were randomized and equally allocated to receive TPR alone (group I) or TPR with LIS (group II). The primary outcome was the clinical improvement of constipation. Secondary outcomes were recurrence of rectocele, operative time, and postoperative complications including fecal incontinence (FI). RESULTS: Clinical improvement of constipation and patients' satisfaction were significantly higher in group II at 1 year of follow-up (93.3 versus 70 %). Constipation scores significantly decreased in both groups postoperatively with more reduction being observed in group II (11.1 ± 2.1 in group I versus 8 ± 1.97 in group II). Significant reduction in the resting anal pressure was noticed in group II. Recurrence was recorded in three (10 %) patients of group I and one patient of group II. No significant differences between the two groups regarding the operative time and hospital stay were noted. CONCLUSION: Adding LIS to TPR of type I rectocele achieved better clinical improvement than TPR alone. The only drawback of LIS was the development of a minor degree of FI, which was temporary in duration.

Place of upper endoscopy before and after bariatric surgery: A multicenter experience with 3219 patients.

AIM: To study the preoperative and postoperative role of upper esophagogastroduodenoscopy (EGD) in morbidly obese patients. METHODS: This is a multicenter retrospective study by reviewing the database of patients who underwent bariatric surgery (laparoscopic sleeve gastrectomy, laparoscopic Roux en Y gastric bypass, or laparoscopic minigastric bypass) in the period between 2001 June and 2015 August (Jahra Hospital-Kuwait, Hafr Elbatin Hospital and King Saud Medical City-KSA, and Mansoura University Hospital - Egypt). Patients with age 18-65 years, body mass index (BMI) > 40, or > 35 with comorbidities after failure of many dietetic regimen and acceptable levels of surgical risk were included in the study after having an informed signed consent. We retrospectively reviewed the medical charts of all morbidly obese patients. The patients' preoperative data included clinical history including upper digestive symptoms and preoperative full workup including EGD. Only patients whose charts revealed weather they were symptomatic or not were studied. We categorized patients accordingly into two groups; with (group A) or without (group B) upper digestive symptoms. The endoscopic findings were categorized into 4 groups based on predetermined criteria. The medical record of patients who developed stricture, leak or bleeding after bariatric surgery was reviewed. Logestic regression analysis was used to identify preoperative predictors that might be associated with abnormal endoscopic findings. RESULTS: Three thousand, two hundred and nineteen patients in the study period underwent bariatric surgery (75% LSG, 10% LRYDB, and 15% MGB). Mean BMI was 43 ± 13, mean age 37 ± 9 years, 79% were female. Twenty eight percent had presented with upper digestive symptoms (group A). EGD was considered normal in 2414 (75%) patients (9% group A vs 66% group B, P = 0.001). The abnormal endoscopic findings were found high in those patients with upper digestive symptoms. Abnormal findings (one or more) were found in 805 (25%) patients (19% group A vs 6% group B, P = 0.001). Seven patients had critical events during conscious sedation due to severe hypoxemia (< 60%). Rate of stricture in our study was 2.6%. Success rate of endoscopic dilation was 100%. One point nine percent patients with gastric leak were identified with 75% success rate of endoscopic therapy. Three point seven percent patients developed acute upper bleeding. Seventy-eight point two percent patients were treated by conservative therapy and EGD was performed in 21.8% with 100% success and 0% complications. CONCLUSION: Our results support the performance of EGD only in patients with upper gastrointestinal symptoms. Endoscopy also offers safe effective tool for anastomotic complications after bariatric surgery.

Is LigaSure a safe cystic duct sealer? An ex vivo study.

BACKGROUND: To compare the efficacy and safety of both mechanical methods (clips) and electrosurgical instruments, harmonic scalpel (HS) and LigaSure (LS), for securing the cystic duct during laparoscopic cholecystectomy (LC). METHODS: During the study period from October 2010 to October 2012, 458 patients with gallbladder stones underwent LC. A total of 38 patients were excluded from the study for different reasons. The gallbladder was excised laparoscopically through the traditional method. The gallbladder specimens of the patients were divided into three equal groups randomly, and the distal part of the cystic duct was sealed ex vivo using ligaclips (Group A), HS (Group B), and LS (Group C). The gallbladders were then connected to a pneumatic tourniquet device and we very gradually increased the pressure with air. The bursting pressure of the cystic duct (CDBP) was measured and differences between the three groups were calculated. RESULTS: The mean CDBP was 329.7 ± 38.8 mmHg in the ligaclip group, 358.0 ± 33.1 mmHg in the HS group, and 219.7 ± 41.2 mmHg in the LS group. A comparison of the mean CDBP between the groups indicated the superiority of HS over ligaclip and LS. CDBP was significantly higher in the ligaclips group compared with the LS group (p <0.001). HS and ligaclips were found to be safe sealers as their mean CDBP was found to be higher (>195 mmHg) than the maximum common bile duct pressure, whereas for LS the CDBP range was 150-297 mmHg, indicating that it is not safe for sealing. CONCLUSION: HS is a safe alternative to clips. In fact, it was even safer than clips. By contrast, LS is not safe for cystic duct sealing.

Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study.

BACKGROUND: This study aimed to compare the short-term outcomes of single-access laparoscopic cholecystectomy (SALC) and conventional laparoscopic cholecystectomy (CLC). METHODS: In a prospective study, patients with symptomatic cholelithiasis were randomized to SALC or CLC with follow-up at 1 week, 1 and 6 months. The primary end point of this study was to assess the total outcomes of quality of life using the EuroQoL EQ-5D questionnaire. The secondary end points were postoperative pain, analgesia requirement and duration of use, operative time, perioperative complications, estimated blood loss, hospital stay, cosmesis outcome, and number of days required to return to normal activities. RESULTS: A total of 269 patients were prospectively randomized into two groups (125 in each group after excluding 19 patients for various reasons). The SALC procedure was done safely without intraoperative or major postoperative complications. In four SALC patients, an extra epigastric port was inserted to enhance exposure. There was no open conversion in either group. SALC patients reported better results among four of the EuroQoL EQ-5D dimensions (mobility, self-care, activity, and pain/discomfort) at 1 week after surgery, an improved pain profile at 4, 12, and 24 h, better cosmetic outcome at 1 and 6 months (P ≤ 0.01), shorter duration of need for analgesia (P ≤ 0.02), and earlier return to normal activities (P ≤ 0.026). Operative times, hospital stay, QOL at 1 and 6 months postoperatively, and estimated blood loss were similar for both procedures. CONCLUSION: This study supports other studies that show that SALC is a feasible and promising alternative to traditional laparoscopic cholecystectomy in selected patients with better cosmesis, QOL, and improved postoperative pain results, and it can be performed with the existing laparoscopic instruments.

Comparative study between Delorme operation with or without postanal repair and levateroplasty in treatment of complete rectal prolapse.

BACKGROUND: Rectal prolapse is a distressing and socially disabling condition. controversy exists regarding the preferred surgical technique for the treatment of complete rectal prolapse. OBJECTIVE: We compared Delorme operation alone or with postanal repair and levatroplasty in treating complete rectal prolapse. METHODS: Consecutive patients treated for rectal prolapse at our colorectal unit were evaluated for inclusion. Participants were randomly allocated to receive Delorme operation only (GI), or Delorme operation with postanal repair and levatorplasty (GII). MAIN OUTCOME MEASURES: The primary outcome measure was recurrence rate; secondary outcomes included improvement of constipation, incontinence, operative time, anal manometery and postoperative complications. RESULTS: Eighty-two consecutive patients with rectal prolapse were randomized. There was a significant difference between the two groups with longer operative time in group II. Recurrence rate after one year was (14.28% in GI, and 2.43% in GII, respectively (P = 0.043). Constipation improved in group I & II but there was a significant difference in constipation scores postoperatively between the two groups. There was improvement in continence mechanism in both groups postoperatively but being higher in group II and this produce a significant statistical difference (0.004). Mean satisfaction score was significantly higher in group II than group I. Both groups succeed to produce a significant change in resting and squeeze pressure before & after the operation. CONCLUSIONS: Delorme operation seems to be an effective procedure for treating complete rectal prolapse especially if combined with postanal repair and levatorplasty. CLINICAL TRIAL REGISTRATION: NCT01656369.

Comparative study of conventional lateral internal sphincterotomy, V-Y anoplasty, and tailored lateral internal sphincterotomy with V-Y anoplasty in the treatment of chronic anal fissure.

BACKGROUND: Lateral internal sphincterotomy has been proven highly effective in curing anal fissure but with a high incidence of postoperative incontinence. OBJECTIVE: We compared conventional lateral internal sphincterotomy, V-Y advancement flap, and combined tailored lateral internal sphincterotomy with V-Y advancement flap in treating anal fissure. PATIENTS: Consecutive patients treated for anal fissure at our colorectal unit were evaluated for inclusion. Participants were randomly allocated to receive conventional sphincterotomy (GI), V-Y advancement flap (GII), or combined tailored lateral sphincterotomy with V-Y advancement l flap (GIII). MAIN OUTCOME MEASURES: The primary outcome measure was the incontinence rate; secondary outcomes included healing rate, operative time, anal manometery, and recurrence rate. RESULTS: One hundred fifty patients with chronic anal fissure were randomized. Healing rate after 1 year was 84% in GI, 48% in GII, and 94% in GIII, respectively (P = 0.001). The recurrence rate was 4% in G1, 22% in GII, and 2% in GIII (P = 0.01). Incontinence rate was 14% in GI, 0% in GII, and 2% in GIII (P = 0.03). CONCLUSION: Although all three procedures are simple and easy to perform, tailored lateral internal sphincterotomy with V-YF appears to produce the greatest healing rate, with the fewest complications and less rate of recurrence.

Early detection of anastomotic leakage after elective low anterior resection.

BACKGROUND: Colorectal anastomotic leakage is a serious complication leading to major postoperative morbidity and mortality. In the present study, we investigated the early detection of anastomotic leakage before its clinical presentation. METHOD: Fifty-six patients with rectal cancer were included prospectively in this study. All patients underwent elective low anterior resection. Peritoneal samples were collected from the abdominal drains at the first, third, and fifth days postoperatively for bacteriological study (quantitative cultures for both aerobes and anaerobes) and cytokines (IL-6, IL-10, TNF) measurement. Patients were divided into two groups: those without symptomatic or clinical evidence of anastomotic leakage (AL; group 1) and those with clinical evidence of AL (group 2). Study variables included hospital stay, wound infection, operative time, blood loss, height of anastomosis, intraperitoneal cytokines, and microbiological study of peritoneal fluid. RESULT: Clinically evident AL occurred in eight patients (14.3%) and diagnosed postoperatively on median day 6. Intraperitoneal bacterial colonization and cytokine levels were significantly higher in patients with clinical evidence of AL. Wound infection was significantly higher in anastomotic leakage group. The hospital stay for the patients with anastomotic leakage was significantly longer than those without AL (14 ± 1.41 vs. 5.43 ± 0.89 days). A significant difference among two groups was observed regarding operative time, blood loss, blood transfusion, and height of the anastomosis. CONCLUSION: The peritoneal cytokines levels and intraperitoneal bacterial colonization might be an additional diagnostic tool that can support the decision making of surgeons for early detection of anastomotic leak in colorectal surgery.