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Completed

NCT Number: NCT03802097

Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy

Laparoscopic gastrectomy has fewer infectious complications compared to open surgery. Recently, the incidence of postoperative infectious complications was greatly reduced due to the development of surgical techniques and improvement of prevention and control of surgical infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not significantly higher than previously reported data.

Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy without prophylactic antibiotics, specially reference to the postoperative infectious complications.

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Key information

Conditions

Gastric Cancer Complication of Surgical Procedure Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hwasun Hospital

Hwasun, Jellanamdo, 58128, South Korea

About this study

The purpose of this study was to investigate the non-inferiority of incidence of infectious complications in the experimental group that did not use prophylactic antibiotics compared to the control group using prophylactic antibiotics.

The primary endpoint is the incidence of surgical site infections within 30 days after surgery and the difference limit of the non-inferiority of the experimental group is assumed to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in the control group is 5% and the incidence of infectious complications in the experimental group is assumed to be about 8%. It is assumed that the significant level is 5% and the power is at least 80%.

According to the above method, a total of 260 patients (130 patients in each group) are needed when 117 patients are needed in each group and about 10% of drop rates and protocol violence are considered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer located in the low or middle part of the stomach
  • A patient who underwent limited lymphadenectomy (D1 or D1+) with clinical T1-2N0M0 stage based on 8th edition of the International Union Against Cancer (UICC) tumor node metastasis (TNM) classification
  • From 18 to 75 years old
  • Eastern Cooperative Oncology Group (ECOG) status 0-1
  • American Society of Anesthesiologists (ASA) score I-II
  • A patient with appropriate bone marrow function, renal function, lung function, and liver function
  • Before the surgery, decide to participate in this study and agree with the written informed consent

Exclusion criteria

  • A patient who underwent previous abdominal surgery
  • Combined other abdominal organ cancer
  • A patient who received chemotherapy and radiotherapy within the last 6 months
  • Combined organ resection other than cholecystectomy
  • A patient undergoing emergency surgery due to perforation or bleeding
  • A patient who have received antibiotic treatment for other infectious diseases within one month of operation
  • Severely malnourished patient

Treatment and study plan

No use of antimicrobial prophylaxis

Procedure

Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

Other names: No AMP

Use of antimicrobial prophylaxis

Procedure

Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

Other names: AMP

Primary outcomes

  1. Incidence of surgical site infections within 30 days

    Time frame: within 30 days after operation

    The diagnosis of infectious complications is made according to the Centers for Disease Control and Prevention (CDC) surgical site infection diagnosis criteria according to physical or radiological findings.

Secondary outcomes

  1. Length of hospital stay

    Time frame: up to 6 months

    From date of operation until the date of hospital discharge

  2. Incidence of remote non-surgical site infections

    Time frame: within 30 days after operation

    Any postoperative infectious complications other than surgical site infections

Sponsors and collaborators

Lead sponsor

Korean South West East Gastric Surgery Group

Other

Registry information

Official study title

Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)

Acronym: KSWEET-03

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2019
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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