Gastric Cancer, Quality of Life, Surgery, Surgical Complication
Conditions
Brief summary
The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.
Detailed description
The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery. Early postoperative morbidity is classified as follows: (1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc. The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires.
Interventions
PROCEDURETLDG arm
After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)
PROCEDURELADG arm
After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)
Sponsors
Shanghai Medical College of Fudan University
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, randomized, multi-center trial that comparing surgical complications and Quality of Life between Totally laparoscopic distal gastrectomy and Laparoscopy-assisted distal gastrectomy in Korea.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy) * Age between 20 and 80 years old * Eastern Cooperative Oncology Group performance statu of 0 or 1 * Clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the American Joint Committee on Cancer system10 (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography) * Scheduled for laparoscopic distal gastrectomy with D1+ or D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2010 (ver.3).) * Patients who gave a consent and signed the formal paper permitted by Institutional Review Board (IRB) after hearing a full description of the study (purpose and contents) prior to the participation
Exclusion criteria
* Patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past * Patients with intraabdominal adhesion due to previous intraperitoneal surgery * Patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy * Patients who requires combined organ resection due to aggression of gastric cancer or other diseases * Patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions). * Vulnerable people who can't communicate or are pregnant (or planning to be pregnant) * Patients who are currently participating or participated in other clinical trials in the last six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative 30-day morbidity rate | Postoperative 30-day | Check the morbidity rate :Wound, seroma, hematoma, wound infection, wound dehiscence, wound evisceration, Fluid collection/Abscess, Intraabdominal bleeding, Intraluminal bleeding, Postoperative ileus, Anastomosis stenosis, Anastomosis leakage, Pancreatitis or pancreatic fistula, Complication(Pulmonary, Urinary, Renal, Hepatic, Cardiac, Endocrine) etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QOL measurement : EORTC QLQ-C30/STO22 | screening(pre op) / Postoperative 30-day,3-month,6-month,12-month | EORTC QLQ-C30/STO22 |
Countries
South Korea
Outcome results
None listed