UMIN-CTR Clinical Trial

Public title

The Study investigating the Impact of Endoscopic Surgical Skill Qualification in Laparoscopic Resection for Rectal Cancer in Japan

Acronym

EnSSURE study

Scientific Title

The Study investigating the Impact of Endoscopic Surgical Skill Qualification in Laparoscopic Resection for Rectal Cancer in Japan

Scientific Title:Acronym

EnSSURE study

Region

Japan

Condition

rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The present study aims to evaluate the impact of the Endoscopic Surgical Skill Qualification on the safety and oncological outcomes of laparoscopic rectal resections for rectal cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postoperative complication rate (Clavien-DIndo classification Grade 3 or above)

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The cases who underwent elective laparoscopic rectal resections for rectal cancer from January 2010 to December 2013 in the institutions enrolled to the Japan Society of Laparoscopic Colorectal Surgery were retrospectively reviewed. The inclusion criteria for this study specified histologically confirmed adenocarcinoma of the rectal tumor located in RS, Ra or Rb. The tumor had to be StageII to StageIII as preoperatively assessment.

Key exclusion criteria

Patients who had other synchronous or metachronous cancers (excluding in situ cancer) within 5 years and received chemotherapy/radiotherapy prior to surgery were excluded.
The cases performed by robotic surgery or cases of colitic cancer were also excluded.

Target sample size

5000

Name of lead principal investigator

1st name	Akinobu
Middle name
Last name	Taketomi

Organization

Graduate school of Medicine, Hokkaido University

Division name

Department of Gastroenterological Surgery 1

Zip code

060-8638

Address

N-15, W-7, Kita-ku, Sapporo

TEL

011-706-5927

Email

taketomi@med.hokudai.ac.jp

Name of contact person

1st name	Nobuki
Middle name
Last name	Ichikawa

Organization

Graduate school of Medicine, Hokkaido University

Division name

Department of Gastroenterological Surgery 1

Zip code

060-8638

Address

N-15, W-7, Kita-ku, Sapporo

TEL

011-706-5927

Homepage URL

Email

n_ichi@pop.med.hokudai.ac.jp

Institute

Hokkaido University

Institute

Department

Personal name

Organization

Department of Gastroenterological Surgery 1, Graduate School of Medicine, Hokkaido University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Japan Society of Laparoscopic Colorectal Surgery

Name of secondary funder(s)

Organization

Hokkaido University Hospital

Address

N-14, W-5, Kita-ku,Sapporo

Tel

011-706-7636

Email

crjimu@huhp.hokudai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

06

Month

03

Day

URL releasing protocol

not available

Publication of results

Published

URL related to results and publications

https://journals.lww.com/aosopen/Fulltext/2022/06000/Impact_of_Endoscopic_Surgical_Skill_Qualificati

Number of participants that the trial has enrolled

3197

Results

A multivariate logistic regression model showed that the adjusted odds ratio of postoperative complications after procedures performed with ESSQS-certified surgeons was 0.68 (P<0.01).

Results date posted

2023

Year

04

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

All elective laparoscopic rectal resections performed from January 2014 to December 2016 at 56 Japanese hospitals belonging to the JSLCS were retrospectively reviewed. The inclusion criteria for this study specified that patients have a histologically confirmed rectal adenocarcinoma, with Stage II or III identified during a clinical preoperative assessment.
Patients who had synchronous or metachronous cancers (excluding in situ cancer) within 5 years and who had undergone multiple intra-abdominal procedures during a single operation, or robotic surgery, were excluded. Patients with ulcerative colitis-associated cancers were also excluded.
A total of 1684 males and 960 females with a mean age of 64.1 years were in the ESSQS group. In the non-ESSQS group, 337 males and 207 females with a mean age of 65.9 years underwent surgery. No differences were observed between the groups in terms of the BMI, frequency of preoperative comorbidities with an ASA class greater than 3, or frequency of patients with preoperative obstructions requiring decompression due to tumors. The ESSQS group had more patients at high-volume centers (50% vs. 35%, P<0.001) and academic institutions (41% vs. 12%, P<0.001) and a higher frequency of low rectal cancers (70% vs. 64%, P<0.001). The distributions of clinical T and N stages were also different between the two groups, though the clinical stage was similar. More patients had undergone preoperative treatment in the ESSQS group (25% vs. 15%, P<0.001). The distributions of the types of procedures were different between the two groups; however, the frequency of lymph node dissections and combined resections of surrounding organs were similar between the groups. High ligations of the IMA (77% vs. 57%, P<0.001), mobilizations of the splenic flexure (10% vs. 2%, P<0.001), lateral pelvic node dissections (20% vs. 8%, P<0.001), and the creation of diverting stomas (34% vs. 27%, P=0.001) were performed more frequently in the ESSQS group.

Participant flow

Among 3197 cases, nine cses were exculded due to synchronous cancer (n=1), multiple intra-abdominal procedures during a single operation (n=6), and othrer reasons (n=2). Overall, 3188 laparoscopic rectal procedures were performed, where 2644 procedures were performed with ESSQS-certified surgeons and 544 procedures were performed without them. ESSQS-certified surgeon contributed as either an operator (n=1843), assistant (n=1357), scope operator (n=159), or advisor (n=33). Multiple ESSQS-certified surgeons were in attendance during surgery in 34% of the procedures.

Adverse events

Not applicable due to the observational study

Outcome measures

the adjusted odds ratio of postoperative complications after procedures performed with ESSQS-certified surgeons

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

03

Month

01

Day

Date of IRB

2020

Year

03

Month

12

Day

Anticipated trial start date

2020

Year

06

Month

01

Day

Last follow-up date

2021

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This cohort study investigates the short- and long-term postoperative outcomes of laparoscopic procedures for rectal cancer performed by or with qualified surgeons compared with outcomes for unqualified surgeons.

Registered date

2020

Year

06

Month

03

Day

Last modified on

2023

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046233