Laparoscopic SurgeryNCT03506555
Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique
A study testing Laparoscopic peritoneal entry technique: Veress needle versus Hasson in people with Laparoscopic Surgery and Laparoscopic Entry Technique, run by Sefako Makgatho Health Sciences University.
Trial summary
A randomised controlled trial (RCT) comparing the closed (Veress needle) with the open (Hasson) laparoscopic entry technique in haemodynamically stable patients undergoing either emergency or elective surgical procedures was conducted over a 13-month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery, Laparoscopic Entry Technique
- What is being tested?
- Laparoscopic peritoneal entry technique: Veress needle versus Hasson
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 1 Feb 2016
- 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
- haemodynamically stable patients, undergoing either emergency or elective laparoscopic general surgical procedures
Who cannot join
- haemodynamically unstable patients, invalid consent
About this study
Official title: Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique: A Randomised Controlled Trial
A randomised controlled trial (RCT) comparing the closed (Veress needle) with the open (Hasson) laparoscopic entry technique in haemodynamically stable patients undergoing either emergency or elective surgical procedures was conducted over a 13-month period. The success rate and complications related to the technique were recorded and analysed.
Read the detailed description
A randomised controlled trial (RCT) was conducted at the single academic tertiary institution (Dr George Mukhari Academic Hospital (DGMAH), South Africa). Patients were recruited over a 13-month period (from 1st November 2014 to 30th November 2015). All haemodynamically stable patients undergoing either emergency or elective laparoscopic procedures were offered to participate in the study. General surgical patients 18 years or older who were eligible to provide an informed written consent were included in the study. Patients younger than 18 years old and haemodynamically unstable patients were excluded from the study. The success rate and complications related to the technique were recorded and analysed.
All included patients were randomised by computer program into one of two arms of the study: the arm A (Veress needle) or the arm B (Hasson). Participating surgeons were fully proficient with both techniques. The periumbilical area and the left hypochondrium (Palmer's point) were the recommended sites of entry, however, depending on clinical situation a surgeon could opt the other areas. In the A arm, a standard reusable Veress needle was used guided by tactile clicks feeling and water drop test. After pneumoperitoneum was established, the trocar was introduced in the same area. In the B arm, the standard open Hasson technique was used by dissecting tissues and dividing peritoneum between two forceps and introducing the port (a sleeve) without a trocar under direct visualization. Failed entry was defined as an inability to access the peritoneal cavity by a surgeon using the access technique initially selected.
An anonymized data collection form was completed by the general surgeon responsible for the procedure. Patients' age, gender, height, weight, diagnosis, type of surgery, previous abdominal surgery, previous abdominal tuberculosis (TB), primary port site placement, a surgeon, intraabdominal findings, complications and their type were recorded. Body Mass Index (BMI) was calculated and patients were categorised into weight groups: BMI above 30 and below 30.
All patients were followed up in 24 hours to detect the early entry-site complications. The complication after 24 hours, including surgical site infection and port-site hernia were not included in the design of this study.
- Conditions
- Laparoscopic Surgery, Laparoscopic Entry Technique
- Being tested
- Laparoscopic peritoneal entry technique: Veress needle versus Hasson
- Keywords
- Laparoscopy, Hasson technique, Veress needle technique, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic peritoneal entry technique: Veress needle versus HassonProcedure or surgery
According to randomization, the closed (Veress needle) or the open (Hasson) laparoscopic entry technique was utilized for general surgical operations
| Study group | Role | What they receive |
|---|---|---|
| the arm A (Veress needle) | Active comparator | a standard reusable Veress needle technique was performed for laparoscopic entry Receives: Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hasson |
| the arm B (Hasson) | Active comparator | the standard open Hasson technique was performed for laparoscopic entry Receives: Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hasson |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate
The technique resulted in establishment of pneumoperitoneum
Measured: during surgery
complications/adverse events related to the technique
Any complications related to the technique
Measured: within 24 hours
Secondary outcomes (1)
Conditions leading to complications/adverse events
Any conditions leading to complications/adverse events were analyzed
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Nov 2014
- Primary completion30 Nov 2015
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sefako Makgatho Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Oleh Matsevych, Sefako Makgatho Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506555
- Sponsor's protocol ID
- SefakoMSU
- Status last verified
- Apr 2018
- First submitted
- 14 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03506555
- Acronym / sponsor ID
- SefakoMSU
- Conditions
- Laparoscopic Surgery, Laparoscopic Entry Technique
- Keywords
- Laparoscopy, Hasson technique, Veress needle technique, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sefako Makgatho Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 24 Apr 2018 (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.
A randomised controlled trial (RCT) comparing the closed (Veress needle) with the open (Hasson) laparoscopic entry technique in haemodynamically stable patients undergoing either emergency or elective surgical procedures was conducted over a 13-month period. The success rate and complications related to the technique were recorded and analysed.
Detailed description
A randomised controlled trial (RCT) was conducted at the single academic tertiary institution (Dr George Mukhari Academic Hospital (DGMAH), South Africa). Patients were recruited over a 13-month period (from 1st November 2014 to 30th November 2015). All haemodynamically stable patients undergoing either emergency or elective laparoscopic procedures were offered to participate in the study. General surgical patients 18 years or older who were eligible to provide an informed written consent were included in the study. Patients younger than 18 years old and haemodynamically unstable patients were excluded from the study. The success rate and complications related to the technique were recorded and analysed.
All included patients were randomised by computer program into one of two arms of the study: the arm A (Veress needle) or the arm B (Hasson). Participating surgeons were fully proficient with both techniques. The periumbilical area and the left hypochondrium (Palmer's point) were the recommended sites of entry, however, depending on clinical situation a surgeon could opt the other areas. In the A arm, a standard reusable Veress needle was used guided by tactile clicks feeling and water drop test. After pneumoperitoneum was established, the trocar was introduced in the same area. In the B arm, the standard open Hasson technique was used by dissecting tissues and dividing peritoneum between two forceps and introducing the port (a sleeve) without a trocar under direct visualization. Failed entry was defined as an inability to access the peritoneal cavity by a surgeon using the access technique initially selected.
An anonymized data collection form was completed by the general surgeon responsible for the procedure. Patients' age, gender, height, weight, diagnosis, type of surgery, previous abdominal surgery, previous abdominal tuberculosis (TB), primary port site placement, a surgeon, intraabdominal findings, complications and their type were recorded. Body Mass Index (BMI) was calculated and patients were categorised into weight groups: BMI above 30 and below 30.
All patients were followed up in 24 hours to detect the early entry-site complications. The complication after 24 hours, including surgical site infection and port-site hernia were not included in the design of this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the arm A (Veress needle) | Active comparator | Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hassona standard reusable Veress needle technique was performed for laparoscopic entry |
| the arm B (Hasson) | Active comparator | Procedure: Laparoscopic peritoneal entry technique: Veress needle versus Hassonthe standard open Hasson technique was performed for laparoscopic entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- haemodynamically stable patients, undergoing either emergency or elective laparoscopic general surgical procedures
Key exclusion criteria (1 listed)
- haemodynamically unstable patients, invalid consent
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 |
|---|---|---|
| Laparoscopic peritoneal entry technique: Veress needle versus HassonAccording to randomization, the closed (Veress needle) or the open (Hasson) laparoscopic entry technique was utilized for general surgical operations | Procedure or surgery | the arm A (Veress needle), the arm B (Hasson) |
Primary outcome
the success rate
Time frame: during surgery
The technique resulted in establishment of pneumoperitoneum
complications/adverse events related to the technique
Time frame: within 24 hours
Any complications related to the technique
1 secondary outcome
Conditions leading to complications/adverse events
Time frame: within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic peritoneal entry technique: Veress needle versus Hasson in people with Laparoscopic Surgery and Laparoscopic Entry Technique, run by Sefako Makgatho Health Sciences University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the success rate (time frame: during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2018; AzTrials last refreshed its copy on 31 Oct 2026.