Stapled Versus Concurrent Stapled And Hand-Sewn Anastomosis In Small Intestine Surgery: An Exploratory Randomized Controlled Trial

AIIMS New Delhi0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•1.18 to 65 years of age both male and female
•2.Patients can follow instructions and are ready for regular follow up
•3. Able to provide informed and written consent
•4.Indications for resection and anastomosis
•a)Non-trauma elective and emergency cases with small intestine perforation or obstruction.
•b)Mesenteric ischemia or strangulation: Small Intestinal obstruction with segmental ischemia or gangrene
•c)Tumour: small bowel mass, Small bowel malignancy with adequate negative margin
•d)Inflammatory bowel disease (Crohn’s enteritis with complications) refractory to conservative treatment or stricture not amenable to stricturoplasty
•e)Entero-cutaneous fistula not amenable to closure or conservative treatment
•f)Symptomatic benign disease such as Meckles diverticulum or perforated diverticulitis or intussusception of bowel needing resection and anastomosis
•g)Incarcerated hernia
•h)Patients with ileostomy for closure

•1.Age < 18 years
•2.Pregnancy
•3.Refusal to consent or participate in the study
•4.Proximal diverting ostomy creation at the time of intestinal anastomosis
•5.Over-sewing of anastomotic edge or anastomotic site omentoplasty was performed
•6.Anastomosis involving oesophagus, stomach, duodenum, colon and rectum
•7.Not amenable for resection and anastomosis surgery based on surgeons judgement:
•a)Anatomical difficulties in applying stapler
•b)Active Inflammatory bowel disease where stricturoplasty was considered
•c)Bowel with doubtful viability or questionable blood supply
•d)Inadequate tumour margin
•e)Patients on immunosuppressive drugs, post-chemotherapy or post-radiotherapy
•f)Hypotension (blood pressure < 90/60 mmHg)

发起方

AIIMS New Delhi