Esophageal CancerRESPECTNCT05553795
Drainless Robot-assisted Minimally Invasive Esophagectomy
A study testing Early removal of chest drain and Chest drain in people with Esophageal Cancer, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Early removal of chest drain and Chest drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- 19 Apr 2023to 21 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
- American Society of Anesthesiologists (ASA) score ≤ III
- Eastern Cooperative of Oncology Group (ECOG) status ≤ II
- Patient suitable for both surgical techniques
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent
Who cannot join
- Open esophagectomy (either abdominal or during the thoracic part)
- Emergency operations
- ASA IV
- ECOG > II
- Chronic pain syndromes requiring routine analgesics
- Simultaneous lung resection
Show all 9Show fewer
- Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)
- Participation in an interventional trial, which interferes with the outcome
- Impaired mental state
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Saxony, 01307
About this study
The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.
- Conditions
- Esophageal Cancer
- Being tested
- Early removal of chest drain, Chest drain
- Keywords
- Esophagectomy, Enhanced Recovery after Surgery (ERAS), Robot-assisted minimally invasive esophagectomy (RAMIE)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early removal of chest drainProcedure or surgery
Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.
Chest drainProcedure or surgery
The chest drains in arm B are removed during the further postoperative course according to standard algorithm.
| Study group | Role | What they receive |
|---|---|---|
| A - Early removal of chest drain | Experimental | Not described Receives: Procedure: Early removal of chest drain |
| B - Control | Other | Not described Receives: Procedure: Chest drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain according to a numeric rating scale
Measured: Day 2 after surgery
Secondary outcomes (6)
Mean postoperative pain
Postoperative pain according to a numeric rating scale
Measured: Day 4 after surgery
Additional analgesic drug use
opioids [mg], non-opioids [mg]
Measured: Day 4 after surgery
Postoperative mobilization
steps per day as measured with an activity tracker
Measured: Day 7 after surgery
Postoperative morbidity
The postoperative morbidity of all patients is assessed with the comprehensive complication index based on Clavien Dindo classification from postoperative day 1 until day of discharge
Measured: Through hospital stay, an average of 14 days
Postoperative mortality
The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay
Measured: Through hospital stay, an average of 14 days
Daily postoperative pain
Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7
Measured: Day 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start19 Apr 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Why it stopped: Following a safety analysis and assessment of the complications encountered by external experts, it was decided to terminate recruitment prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled multicentric trial
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Johanna Kirchberg, Dr. med., Principal investigator, Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553795
- Sponsor's protocol ID
- VTG-11
- Acronym
- RESPECT
- Status last verified
- Jun 2024
- First submitted
- 19 Aug 2022
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mussle B, Kirchberg J, Buck N, Radulova-Mauersberger O, Stange D, Richter T, Muller-Stich B, Klotz R, Larmann J, Korn S, Klimova A, Grahlert X, Trips E, Weitz J, Welsch T. Drainless robot-assisted minimally invasive oesophagectomy-randomized controlled trial (RESPECT). Trials. 2023 May 2;24(1):303. doi: 10.1186/s13063-023-07233-z.
PubMed 37127683
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainless Robot-assisted Minimally Invasive Esophagectomy
- ClinicalTrials.gov ID
- NCT05553795
- Acronym / sponsor ID
- RESPECT / VTG-11
- Conditions
- Esophageal Cancer
- Keywords
- Esophagectomy, Enhanced Recovery after Surgery (ERAS), Robot-assisted minimally invasive esophagectomy (RAMIE)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following a safety analysis and assessment of the complications encountered by external experts, it was decided to terminate recruitment prematurely
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled multicentric trial
| Arm | Type | Receives |
|---|---|---|
| A - Early removal of chest drain | Experimental | Procedure: Early removal of chest drain |
| B - Control | Other | Procedure: Chest drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
- American Society of Anesthesiologists (ASA) score ≤ III
- Eastern Cooperative of Oncology Group (ECOG) status ≤ II
- Patient suitable for both surgical techniques
- Ability of subject to understand character and individual consequences of the clinical trial
Key exclusion criteria (9 listed)
- Open esophagectomy (either abdominal or during the thoracic part)
- Emergency operations
- ASA IV
- ECOG > II
- Chronic pain syndromes requiring routine analgesics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early removal of chest drainChest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A. | Procedure or surgery | A - Early removal of chest drain |
| Chest drainThe chest drains in arm B are removed during the further postoperative course according to standard algorithm. | Procedure or surgery | B - Control |
Primary outcome
Postoperative pain
Time frame: Day 2 after surgery
Postoperative pain according to a numeric rating scale
6 secondary outcomes
Mean postoperative pain
Time frame: Day 4 after surgery
Additional analgesic drug use
Time frame: Day 4 after surgery
Postoperative mobilization
Time frame: Day 7 after surgery
Postoperative morbidity
Time frame: Through hospital stay, an average of 14 days
Postoperative mortality
Time frame: Through hospital stay, an average of 14 days
Daily postoperative pain
Time frame: Day 7 after surgery
Results and safety
The study was stopped early (reason given: Following a safety analysis and assessment of the complications encountered by external experts, it was decided to terminate recruitment prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 37127683Mussle B, Kirchberg J, Buck N, Radulova-Mauersberger O, Stange D, Richter T, Muller-Stich B, Klotz R, Larmann J, Korn S, Klimova A, Grahlert X, Trips E, Weitz J, Welsch T. Drainless robot-assisted minimally invasive oesophagectomy-randomized controlled trial (RESPECT). Trials. 2023 May 2;24(1):303. doi: 10.1186/s13063-023-07233-z.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Kirchberg, Dr. med. principal investigator
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early removal of chest drain and Chest drain in people with Esophageal Cancer, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Following a safety analysis and assessment of the complications encountered by external experts, it was decided to terminate recruitment prematurely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Day 2 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.