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Abdominal approach D2 total gastrectomy with Roux-en-Y+Pouch anastomosis. Roux-en-Y+Pouch anastomosis: closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm.

Abdominal approach D2 total gastrectomy with Roux-en-Y anastomosis. Roux-en-Y anastomosis : closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, œsophago-jejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm

Roux-en-Y anastomosis

Roux-en-Y+Pouch anastomosis

Jian-Kun Hu, M.D., Ph.D.

Wei-Han Zhang, M.D.

Pei-Wu Yu, M.D.,Ph.D.

Chao-Jun Zhang, M.D.,Ph.D.

Quan-Lin Guan, M.D.

Kai-Xiong Tao, M.D.,Ph.D.

Xiang-ming Che, M.D.,Ph.D.

Xiang-Ming Che, M.D.,Ph.D.

Xian-Li He, M.D.,Ph.D.

Xian-Li He, M.D.

Qing-Chuan Zhao, M.D.,Ph.D.

Jian-Kun Hu, M.D.,Ph.D.

Jian-Kun Hu, M.D.

Kun-Hua Wang, M.D.

Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of life, controversies still exist to the reconstruction methods of total gastrectomy. Although roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an easily and safety method reconstruction method, but some problems still need us to solve, such as little food reserves, less food intake per meal and fast gastric emptying. These problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch anastomosis is newly born method can significant increase the volume to improve postoperative quality of life have been proven by some little sample size randomized control trail With the improvement of the gastric cancer surgery, this study proposed by prospective randomized controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of life was evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy.

Consecutive patients in each participant units and satisfied with inclusion/exclusion criteria will be informed the details, right, responsibility possible benefit and potential risks when after join in this study. Those patients who agree and sign informed consent document will randomized, consecutive case series sampling.

All the patients in the study and finished sampling would and must be recorded in the Western China Gastric Cancer Collaboration database and assign to corresponding treatment group.

Randomization allocation

After intraoperative exploration and predictively D2 radical (R0) total gastrectomy is possible to be performed, then assigned randomly to each subject on a 1:1 basis to either the Roux-en-Y+Pouch group or the Roux-en-Y group.

Surgical treatment

Surgical approach: open total gastrectomy. Surgical treatment method: Radical total gastrectomy (R0); D2 lymph-node dissection (No.1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 10, 11p, 11d, 12a,19,20); Abscission pneumogastric nerve trunk.

Reconstruction method:

Group A (Roux-en-Y type): closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, esophagojejunal anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm; Group B (Roux-en-Y+Pouch type): closed the stump of duodenum, cut off the jejunum from the 20cm of Treitz ligament, pouch reconstruction a J pouch with a length of 15 cm was constructed by connecting the 2 Jejunal lumina, œsophago-P type jejunum Storage bag anastomosis (duct-to-duct / duct-to-duct, before the colon/after the colon), jejunum - jejunum anastomosis (duct-to-duct / duct-to-duct), the distance between anastomotic were 40cm-60cm

Quality control of surgery:

All the surgical treatments will be performed by member of Western China Gastric Cancer Collaboration. Quality supervision within groups to avoid the bias.

Intraoperative photograph after the lymphadenectomy and the reconstruction of the digestive tract is essential.

Follow-up and Database

Follow-up programming:

Postoperative follow-up and assessment will be performed by specially researchers arrange by each units and blind to randomize allocation; Postoperative long term follow-up will be conducted in 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy; Face to face interview is necessary and the postoperative quality of life questionnaire is done by the patients themselves.

Management of the database:

The design of this study database was responsible for the leading units; Each cases of this study should and must have a uniform case reported form, include demographic data, operation data, pathological information and Postoperative quality of life evaluation; A file included in the Case Report Form (CRF) was record follow-up information last to three years after surgery.

Lost follow-up:

Three years lost follow-up rates should below 10%. Lost follow-up rate will reported in final reports, and cases of lost follow-up will take the intention-to-treat (ITT) method to analysis.

Statistics analysis The measurement data strictly obey normal distribution are presented as means (±SD) and compared with single factor analysis of variance.

The measurement data do not obey normal distribution are presented as median and compared with Wilcoxon test.

Categorical data are presented percentage and compared with the Chi-square test.

Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy

Jejunal Pouch for Postoperative Quality of Life Following Roux-en-Y Reconstruction of Radical Total Gastrectomy: a Multicenter Randomized Controlled Trial (WCGCC-1202)

Postoperative quality of life is evaluated by the EORTC QLQ-C30 and the EORTC QLQ-STO22

West China Hospital

Professor

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Construction of a gastrointestinal anastomoses

Monosyn will be used to perform the gastrointestinal anastomoses

Monosyn

The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.

Postoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints.

The question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.

An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract

An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.

Anastomotic leak is defined as radiographic demonstration of a fistula or non-absorbable material drainage from a wound after oral administration, or visible disruption of the suture line during re-exploration.

As postoperative complications the following parameter will be documented: peritonitis, wound infection, bleeding, abscess, fistula, perforation, obstipation and stenosis. Wound infections, peritonitis and abscess are defined according to the Centres for Disease Control and Prevention (CDC, 17).

Duration from day of operation until the day of discharge from the hospital.

Duration from the first day in the ICU until the last day in the ICU. In the case of readmission to the ICU the sum of all days within the ICU.

The time recorded for the construction of the anastomosis begins with the placement of the first stitch and ends with cutting the excess material from the last stitch.

Calculation of the cost of material is based on the actual hospital costs for the suture material and the number of used threads by the surgeon.

For the calculation of the operation costs, the time to perform the anastomosis will be multiplied with the cost of one operation minute (50-100 €).

Intra-operative handling of the suture material will be reported on a separate document one time per participating surgeon at the end of the study. The following criteria will be assessed:

knot security, knot pull tensile strength, knot run-down, tissue drag, elasticity and feeling of the suture material. For the rating a 5-point scale is used

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy	NCT02110628	Gastric Cancer Roux-en-y Anast... Gastric Anastom... Quality of Life Complication	Roux-en-Y anast... Roux-en-Y+Pouch...	18 Years - 75 Years	West China Hospital
Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy	NCT02110628	Gastric Cancer Roux-en-y Anast... Gastric Anastom... Quality of Life Complication	Roux-en-Y anast... Roux-en-Y+Pouch...	18 Years - 75 Years	West China Hospital
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract	NCT02080702	C.Surgical Proc... Symptomatic Dis... Gastric Anastom... Gastrointestina...	Monosyn	18 Years -	Aesculap AG

Spots Global Cancer Trial Database for gastric anastomosis (site)