TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

Ulcerative Colitis Clinical Trial

Official title:

Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536988
• Other study ID #: JinlingH TAMIS
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2018
• Source: Jinling Hospital, China
• Contact: Jianfeng Gong, MD
• Phone: +86-25-80860036
• Email: gongjianfeng[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ileal Pouch
• Postoperative Complications
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• TAMIS-IPAA
In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
• Lap-IPAA
In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Complications	Postoperative complcations were documented using comprehensive complication index(CCI)	Day 30
Secondary	Duration of operation	The duration of operation will be documented in minutes, from skin incision to dress coverage	24 Hr
Secondary	The incidence of pouch extension	the need to extend the length of pouch during operation	24 Hr
Secondary	Intraoperative complications	Including anastomotic burst, iatrogenic injury	24 Hr
Secondary	Estimated blood loss	in mLs during surgery	24 Hr
Secondary	Postoperative anastmotic leakage	Anastomotic leakage was defined as any defect at the anastomotic site confirmed by imaging or during surgical re-intervention, and was categorised according to the impact on clinical management [A, B, C]. Grade A leaks had minimal to no clinical impact on the patient's postoperative course, requiring antibiotics at the most. Grade B leaks required active intervention such as radiological placement of a pelvic drain or transanal lavage. Grade C leaks required re-operation, mostly because the patient was not defunctioned.	Day 90
Secondary	Time to GI-2 recovery	Time to GI-2 recovery, a composite end point of the later of upper (first toleration of solid food) and lower (first bowel movement) GI function.	Day 90
Secondary	Postoperative length of hospital stay	in days	Day 90
Secondary	Overall cost of treatment	In Chinese Yuan (CNY)	up to 1 year
Secondary	Remaining length of anal mucosa.	The mean lenght of four quadrant during pouchoscopy 2 months after opertion, the length was calculated from the dental line to the anastomotic site.	24 Hr
Secondary	The incidence of cuffitis and pouchitis	Pouchitis is defined as inflammatory condition of the ileal pouch reservoir, while cuffitis is defined as the inflammatory condition of the remnant rectal cuff.	up to 1 year
Secondary	Postoperative quality of life	Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)	up to 1 year