UMIN-CTR Clinical Trial

Basic information
Public title	Effect of intraperitoneal drainage on postoperative quality of life after laparoscopic colon surgery
Acronym	A study of the effect of drains on postoperative quality of life after colon surgery
Scientific Title	A randomized controlled trial of the effect of intraperitoneal prophylactic drain placement on postoperative quality of life after elective laparoscopic colon surgery
Scientific Title:Acronym	A randomized controlled trial of the effect of intraperitoneal prophylactic drain placement on postoperative quality of life after elective laparoscopic colon surgery
Region	Japan

Condition
Condition	colon surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The effect of intraperitoneal prophylactic drains on postoperative quality of life after laparoscopic colon surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	SF-8 mental health score on postoperative day 3
Key secondary outcomes	Preoperative SF-8 Physical Health Score Preoperative SF-8 mental health score SF-8 physical health score on postoperative day 3 SF-8 physical health score on postoperative day 5 SF-8 mental health score on postoperative day 5 SF-8 physical health score at 1 month postoperatively SF-8 mental health score at 1 month postoperatively Incidence of infectious complications period of hospitalization post-operative pain NRS on postoperative day 1 NRS on postoperative day 3 NRS on post-operative day 5 The eight subscales of the preoperative SF-8 (Physical functioning, daily role functioning, body pain, overall sense of health, vitality, Social life functioning, daily role functioning (mental) and mental health) Eight subscales of the SF-8 on postoperative day 3 (physical functioning, daily role functioning, body pain, overall sense of well-being, vitality, social functioning, daily role functioning (mental), and mental health) Eight subscales of the SF-8 on postoperative day 5 (physical functioning, daily role functioning, body pain, overall sense of well-being, vitality, social functioning, daily role functioning (mental), and mental health) Eight subscales of the SF-8 at 1 month postoperatively (physical functioning, daily role functioning, body pain, overall sense of well-being, vitality, social functioning, daily role functioning (mental), and mental health)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Place an intraperitoneal drain.
Interventions/Control_2	No intraperitoneal drains in place.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing laparoscopic colon surgery
Key exclusion criteria	Patients with peritonitis Patients with serious lung disease with a rate of less than 50% per second Patients with serious cardiac conditions of NYHA III or higher Patients with HbA1c 8.0 or higher at the time of enrollment and with diabetes Patients with cirrhosis of the liver with a Child classification of B or greater Patients with impaired renal function with a serum Cr of 2 mg/dl at enrollment Patients on dialysis Patients with undecompressed preoperative bowel obstruction Patients who received systemic steroids within 28 days prior to enrollment Patients unable to obtain informed consent Patients unable to complete the survey Emergency surgery patients. Patients who are considered inappropriate by their physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Miyake
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2238
Email	hqsurge1@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Miyake
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2238
Homepage URL
Email	hqsurge1@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiga University of Medical Science Research Ethics Committee.
Address	Seta Tsukinowa-cho, Otsu, Shiga
Tel	077-548-3576
Email	hqrec@belle.shiga-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	滋賀医科大学医学部附属病院 (Shiga University of Medical Science Hospital)

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 07 Month 21 Day
Date of IRB	2020 Year 08 Month 21 Day
Anticipated trial start date	2020 Year 10 Month 15 Day
Last follow-up date	2023 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 08 Day
Last modified on	2020 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047997