Discussion
pain, infection, fistula, primary tumor, sepsis, nerve damage, trauma
TUMOR RECURRENCE, RECURRENCE, SCAR, INFECTION, PRIMARY TUMOR, SEPSIS, POSTOPERATIVE STRICTURE, RECTAL CANCER, COMPLICATIONS
Firstly, there is great deference in terms of perforation, leak and fistula. Perforation means acute full thickness (transmural) defect in the gastrointestinal tract, occurring either spontaneously or due to trauma (after an injury and iatrogenic) [There is an algorithm for management of leak and fistula. Regarding the fistula management, drainage of any collection by interventional radiology with concurrent antibiotics & nutritional status improvement are the first steps, then the management depends on the size of fistula: (a) if the size is more than 2 cm, it needs fistulotomy; (b) if size is less than 2 cm, attempts of primary closure should be tried; (c)if size of fistula is less than 10 mm, the OTSC is used; (d) if the size of fistula more than 10 mm but less than 2 cm, Endo-stitch devise is used [For leak, the management algorithm depends on the clinical status for the patient: (a) if patient presents with unstable clinical condition, he will be subjected for surgery; (b) if presenting with stable clinical condition, the patient will be subjected for endoscopic management according to size of the leak: (b.1) if the size is more than 2 cm, it needs resection & anastomosis; (b.2) if the size is less than 2 cm, attempts of primary closure should be tried; (b.3) if the size of fistula is less than 10 mm, the OTSC is used; (b.4) if the size of fistula is more than 10 mm but less than 2 cm, Endo-stitch device is used [In this study, for closure of low output fistula or colonic defect with size of less than 1.5 cm, the investigators used OTSC (over-the-scope clips) and Endo-suturing device. OTSC was used to close colonic defect or fistula with size of less than 1 cm. The investigators in this study used OTSC with no evidence of clip migration or postoperative stricture during the postoperative follow-up period [There are many advantages of endoscopy that made it a cornerstone in managing such type of fistula & leak like shorter hospital stay, no abdominal scar, less pain, low incidence of surgical trauma, early return to normal active life, low incidence of infection, rapid recovery, and low incidence of nerve damage.Regarding post-operative complications in the endoscopic group, recurrence of fistula occurred in four patients due to lack of adequate experience, inadequate drainage of peritoneal collections, recurrence of primary tumor due to delay in postoperative adjuvant chemo-radiotherapy due to delay in management of fistula and inadequate nutrition. Abdominal collection in this group (EG) occurred in three patients due to recurrence of fistula or leak and inadequate drainage of peritoneal collections. In the surgical group, recurrence occurred in 8 patients due to inadequate surgical repair, recurrence of primary tumor due to delay in postoperative adjuvant chemo-radiotherapy and poor nutritional status. Abdominal collection in this group (SG) occurred in 8 patients due to recurrence of fistula or leak and inadequate drainage of peritoneal collections. In Surgery Group, one patient died due to recurrence of fistula or leak with uncontrolled sepsis. Staging of the rectal cancer did not affect healing of fistula in both groups as healing of fistula depended mainly on proper control of sepsis, improvement of nutritional status, absence of distal obstruction, surgeon's experience, no tumor recurrence and adequate safety margin of primary surgery.Regarding quality of life, we used WHOQOL-BREF questionnaire that has 26 items. This questionnaire has four domains included physical health (seven items), psychological (six items), social relationship (three items) and environmental health (eight items); it also has QOL and general health items. Each separate item is scored from 1 to 5 on a response scale. The scale is then stipulated as a five point ordinal scale. The score is then changed linearly to a 0–100 scale. The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep. The psychological domain includes items on self-image, negative thoughts, positive attitude, self-esteem, mentality, learning ability, memory concentration, religion, and mental status. The social relationship domain includes items on personal relationship, social support, and sex life. The environmental heath includes items on financial resources, safety, health and social services, living physical environment, opportunities to acquire new skills and knowledge, recreation, general environment (noise, air pollution, etc.), and transportation. The score below 50 means poor quality of life, score between 50 to 75 means good quality of life and score more than 75 means excellent or high quality of life [The main limitations of this study are small sample size, exclusion of patients with ASA III and IV, short follow-up period, large sized defect more than 2 cm can't be managed by clipping or Endo-stitch and de-epithelization of the edge of the defect that was done by argon plasma or mechanical scratching depended on the endoscopist own experience. However, the point of strength of this study was being of randomized clinical trial comparing different modalities of the endoscopic approach on one hand and surgical approach on the other hand [