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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
RECRUITINGPostoperative Complications
Postoperative complcations were documented using comprehensive complication index(CCI)
Time frame: Day 30
Duration of operation
The duration of operation will be documented in minutes, from skin incision to dress coverage
Time frame: 24 Hr
The incidence of pouch extension
the need to extend the length of pouch during operation
Time frame: 24 Hr
Intraoperative complications
Including anastomotic burst, iatrogenic injury
Time frame: 24 Hr
Estimated blood loss
in mLs during surgery
Time frame: 24 Hr
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.
Time frame: Day 90
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.
Time frame: Day 90
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Postoperative length of hospital stay
in days
Time frame: Day 90
Overall cost of treatment
In Chinese Yuan (CNY)
Time frame: up to 1 year
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.
Time frame: 24 Hr
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.
Time frame: up to 1 year
Postoperative quality of life
Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)
Time frame: up to 1 year