TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

Jinling Hospital, China

Status: Unknown

Conditions: Postoperative Complications; Ileal Pouch; Ulcerative Colitis

Treatments: Procedure: Lap-IPAA; Procedure: TAMIS-IPAA

Study type: Interventional

Funder types: Other

Identifiers

NCT03536988

JinlingH TAMIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

TAMIS-IPAA

Experimental group

Description:

In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.

Treatment:

Procedure: TAMIS-IPAA

Lap-IPAA

Active Comparator group

Description:

In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.

Treatment:

Procedure: Lap-IPAA