A study to observe correlation between resection and reconstruction procedures employed for gastric neoplasms and development of postgastrectomy syndrome

Not Applicable

• Conditions: Gastric cancer patients who underwent various types of gastrectomy (GIST patients who underwent gastric wedge resection are also included)

• Registration Number: JPRN-UMIN000002116
• Lead Sponsor: Department of Surgery, The Jikei University School of Medicine

Brief Summary

1. Nakada K, et al. Characteristics and clinical relevance of postgastrectomy syndrome assessment scale (PGSAS)-45: newly developed integrated questionnaires for assessment of living status and quality of life in postgastrectomy patients. Gastric Cancer. 2015 Jan;18(1):147-58. 2. Terashima M, et al. Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 and Changes in Body Weight are Useful Tools for Evaluation of Reconstruction Methods Following Distal Gastrectomy. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S370-8. 3. Namikawa T, et al. Factors that minimize postgastrectomy symptoms following pylorus-preserving gastrectomy: assessment using a newly developed scale (PGSAS-45). Gastric Cancer. 2015 Apr;18(2):397-406. 4. Takiguchi N, et al. Long-term quality-of-life comparison of total gastrectomy and proximal gastrectomy by Postgastrectomy Syndrome Assessment Scale (PGSAS-45): a nationwide multi-institutional study. Gastric Cancer. 2015 Apr;18(2):407-16. 5. Misawa K, et al. Evaluation of postgastrectomy symptoms after distal gastrectomy with Billroth-I reconstruction using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45). Gastric Cancer. 2015 Jul;18(3):675-81. 6. Inada T, et al. Evaluation of QOL After Proximal Gastrectomy Using a Newly Developed Assessment Scale (PGSAS-45). World J Surg. 2014 Dec;38(12):3152-62. 7. Kawahira H, et al. Optimal Roux-en-Y reconstruction after distal gastrectomy for early gastric cancer as assessed using the newly developed PGSAS-45 scale. Surg Today. 2015 Oct;45(10):1307-16. 8. Fujita J, et al. Assessment of postoperative quality of life following pylorus-preserving gastrectomy and Billroth-I distal gastrectomy in gastric cancer patients: results of the nationwide postgastrectomy syndrome assessment study. Gastric Cancer 2016 Jan; 19(1): 302-311.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-25
• Study Completion: 2010-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 5600

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Active dual malignancy. (2) Patients who underwent concomitant resection of other organ(s) due to another disease (co-resection equivalent to cholecystectomy being the exceptions). (3) Considered as unsuitable to participate in the study by a surgeon who is in charge.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the degree of generic QOL (SF-8), symptom specific QOL (GSRS), other abdominal symptoms, ingested amount, weight loss and satisfaction.

Secondary Outcome Measures

Name	Time	Method
To investigate the correlation between above mentioned factors.