Single-incision transumbilical laparoscopic Roux-en-Y gastric bypass

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Chih-Kun Huang
Scientific

Yi-Da Road
Kaohsiung County
824
Taiwan

Primary study design	Interventional
Study design	Prospective non-randomised controlled study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Single-incision transumbilical laparoscopic Roux-en-Y gastric bypass: a prospective non-randomised controlled study
Study objectives	1. To evaluate the feasibility and safety of single-incision transumbilical laparoscopic Roux-en-Y gastric bypass 2.To compare the surgical outcome of the single incision transumbilical and 5-ports laparoscopic Roux-en-Y gastric bypass
Ethics approval(s)	E-Da Institutional Review Board (IRB) approved on the 13th August 2009 (ref: EMRP17098N)
Health condition(s) or problem(s) studied	Morbid obesity/type II diabetes meliitus
Intervention	The study prospectively compares single incision transumbilical laparoscopic Roux en Y gastric bypass (intervention arm) and conventional 5-port laparoscopic Roux en Y gastric bypass (control arm). Patients can choose which surgery they prefer for themselves. The total duration for treatment is 2 years and all patients are followed 2 years.
Intervention type	Other
Primary outcome measure(s)	Measured peri-operatively and 3 months post-operatively: 1. Operation time 2. Intra-operative complication 3. Post-operative complication 4. Analgesic use 5. Hospitalisation
Key secondary outcome measure(s)	1. Excess weight loss in first year, measured at 1, 3, 6, 9 and 12 months 2. Wound satisfaction, measured at 3 months
Completion date	31/12/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	All patients (aged 18 - 65 years, either sex) considered for laparoscopic Roux-en-Y gastric bypass as the treatment method for morbid obesity or Type II Diabetes mellitus
Key exclusion criteria	1. Body mass index (BMI) greater than 50 2. Body height greater than 180 cm
Date of first enrolment	01/11/2008
Date of final enrolment	31/12/2010

Yi-Da Road

Kaohsiung County
824
Taiwan

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes