Clinical trial NCT03536988: TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis
Official title: Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Postoperative Complications
Ileal Pouch
Keywords: Ulcerative Colitiis
Ileal pouch anal anastomosis
Transanal Minimally Invasive Surgery
Postoperative Outcome
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative Complications
timeFrame: Day 30
Secondary outcomes:
measure: Duration of operation
timeFrame: 24 Hr
measure: The incidence of pouch extension
timeFrame: 24 Hr
measure: Intraoperative complications
timeFrame: 24 Hr
measure: Estimated blood loss
timeFrame: 24 Hr
measure: Postoperative anastmotic leakage
timeFrame: Day 90
measure: Time to GI-2 recovery
timeFrame: Day 90
measure: Postoperative length of hospital stay
timeFrame: Day 90
measure: Overall cost of treatment
timeFrame: up to 1 year
measure: Remaining length of anal mucosa.
timeFrame: 24 Hr
measure: The incidence of cuffitis and pouchitis
timeFrame: up to 1 year
measure: Postoperative quality of life
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Jianfeng Gong
role: PRINCIPAL_INVESTIGATOR
References: