Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Jinling Hospital, China
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Postoperative Complications
- Last Updated
- 7 years ago
Overview
Brief Summary
The objective of this RCT is to compare the postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.
Detailed Description
Theoritically, the advantge of TAMIS surgery over traditional trans-abdominal IPAA surgery incudes shorter operation time due to simulatous surgery transanlly and transabdominally, reduced operative difficulty in narrow male pelvis, less retained rectal cuff and less "dog-ear" formation. However, its adgange has not been proven in prospecitve randomized trials. The aim of current study is to compare the short and long-term postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.
Investigators
Jianfeng Gong
associate professor
Jinling Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Clincially and pathologically proven ulcerative colitis
- •Aged 18-75 years
- •Patients who will undergo proctectomy and IPAA surgery, incuding the first stage of two-stage surgery, or the second stage of three-stage or modified two-stage surgery
- •Elective surgery
- •Informed constent obtained.
Exclusion Criteria
- •A contraindication for minimally invasive surgery or TAMIS surgery
- •Ileus or peritonitis
- •Previous surgery in rectum
- •Pregnancy
- •Carcinogenesis of rectum, dysplasia or stricture of ATZ, or planned mucosectomy
- •Patients with planned permnant ileostomy
Outcomes
Primary Outcomes
Postoperative Complications
Time Frame: Day 30
Postoperative complcations were documented using comprehensive complication index(CCI)
Secondary Outcomes
- Postoperative quality of life(up to 1 year)
- Intraoperative complications(24 Hr)
- Time to GI-2 recovery(Day 90)
- The incidence of cuffitis and pouchitis(up to 1 year)
- The incidence of pouch extension(24 Hr)
- Postoperative anastmotic leakage(Day 90)
- Overall cost of treatment(up to 1 year)
- Remaining length of anal mucosa.(24 Hr)
- Estimated blood loss(24 Hr)
- Postoperative length of hospital stay(Day 90)
- Duration of operation(24 Hr)