Esophageal CancerNCT05662644
Assessment of Minimally Invasive Surgery for Esophageal Cancer
A study testing Minimally Invasive Surgery for Esophageal Cancer in people with Esophageal Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding 1. Surgical technique: A totally minimally invasive technique (combined thoracoscopic and laparoscopic approaches) for esophagectomy will be used in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Minimally Invasive Surgery for Esophageal Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any age.
- Any sex.
- Diagnostic operable esophageal cancer.
Who cannot join
- Metastatic patients.
- Locally advanced cases.
- Patients with comorbidities who are unfit for major surgical procedures.
- Patients with contraindications for laparoscopy or thoracoscopy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag university
Sohag, 82511
Ahmed A Kenawy, MD candidate, 1021025880 ext. +20, ahmed.qenawi@med.sohag.edu.eg
About this study
Official title: Minimally Invasive Surgery for Esophageal Cancer: Feasibility and Outcome
Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding
- Surgical technique: A totally minimally invasive technique (combined thoracoscopic and laparoscopic approaches) for esophagectomy will be used in this study. Also, a hybrid technique (thoracoscopic approach with laparotomy or laparoscopic approach with thoracotomy) will be included.
- Histopathology
- Assessment of surgical margins
- Assessment of the number of lymph nodes
- Peri-operative outcome including
- Operative time
- Conversion to open
- Blood loss
- Hospital stays
- Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
- Morbidity and mortality.
Read the detailed description
Introduction
Esophageal cancer is the seventh most common cause of cancer-related death worldwide. The overall five-year survival is below 20%.
It is characterized by its high mortality rate, poor prognosis at time of diagnosis and variability based on geographic location. Now , the prevalence of esophageal cancer is in transition .
The Arabic world has very low incidences of Esophageal cancer in general. In Egypt, it represents 1.7% of all cancers.
Esophagectomy followed by reconstruction surgery has been the most reliable modality for treatment in patients without evidence of disease spread.
Different surgical approaches, such as the Sweet esophagectomy, Ivor Lewis esophagectomy, McKeown esophagectomy, and transhiatal esophagectomy, have been used clinically based on specific locations in the esophageal cancer.
For cancer of the middle or lower segment of the thoracic esophagus, the Ivor Lewis esophagectomy and the Sweet esophagectomy through the left thoracic approach are the mainstream standard surgical approaches.
Conventional surgical treatment involves open esophagectomy (OE) using transthoracic or transhiatal approaches which are associated with high mortality and morbidity especially respiratory complications (RCs) that are common with open esophagectomy and can increase the risk of death by up to 20%.
Traditionally, an esophagectomy was performed through a right thoracotomy and laparotomy. However, these patients are at a high risk for developing postoperative pulmonary complications. In order to decrease postoperative morbidity, minimally invasive surgical techniques were introduced in the treatment of esophageal cancer.
The first thoracoscopic esophageal mobilizations for esophagectomy were performed in the early 1990s by A. Cuschieri.
Then, DePaula and colleagues and Swanström and Hansen separately published the first totally minimally invasive transhiatal esophagectomies in 1995 and 1997, respectively. Subsequently, many centers began to adapt their preferred technique to minimally invasive approaches and gained significant experience in laparoscopic and thoracoscopic approaches to esophagectomy.
Luketich et al. first identified the combined thoracoscopic esophageal mobilization followed by the laparoscopic fashioning of the gastric conduit and the development of an esophagogastric anastomosis in the cervical region.
In recent decades, minimally invasive esophagectomy (MIE) has become an alternative to open esophagectomy. minimally invasive esophagectomy (MIE) involves several techniques including total MIE (tMIE), hybrid minimally invasive esophagectomy (hMIE), and robotic surgery .
The procedure consists presently of three main techniques: combined thoracoscopic and laparoscopic approach (Ivor Lewis); thoracoscopic, laparoscopic, and cervical approach (three-hole); or laparoscopic and cervical approach only (transhiatal).
Luketich et al. subsequently published their approach to minimally invasive Ivor Lewis esophagectomy and intrathoracic anastomosis and concluded that this type of treatment is feasible.
MI McKeown esophagectomy procedure consists of thoracoscopic esophagectomy, laparoscopic gastric mobilization, and cervical anastomosis between the esophageal stump and gastric stump. With the improvement of techniques and equipment, McKeown MIE has received increased attention.
Objectives:
Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding
- Surgical technique: A totally minimally invasive technique (combined thoracoscopic and laparoscopic approaches) for esophagectomy will be used in this study. Also, a hybrid technique (thoracoscopic approach with laparotomy or laparoscopic approach with thoracotomy) will be included.
- Histopathology
- Assessment of surgical margins
- Assessment of the number of lymph nodes
- Peri-operative outcome including
- Operative time
- Conversion to open
- Blood loss
- Hospital stays
- Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
- Morbidity and mortality.
Aim of the work This study aims to evaluate the feasibility and outcome of minimally invasive management of esophageal cancer.
Study Design:
This study is going to be a prospective study where patients presenting with esophageal cancer who are considered candidates for surgery will undergo minimally invasive surgery. Each patient will be assessed in the pre, intra, and short postoperative period.
Methodology:
- Population of study \& disease Condition patients with esophageal cancer.
- Background and Demographic characteristics Any patient with esophageal cancer is considered a candidate for a minimally invasive esophagectomy procedure.
- Inclusion criteria:
- Any age.
- Any sex.
- Diagnostic operable esophageal cancer.
- Exclusion criteria:
- Metastatic patients.
- Locally advanced cases.
- Patients with comorbidities who are unfit for major surgical procedures.
- Patients with contraindications for laparoscopy or thoracoscopy.
- Interventions: Patients with esophageal cancer who are considered candidates for surgery will be subjected to minimally invasive procedures through a combined laparoscopic and thoracoscopic approach with D2 dissection and mediastinal dissection.
- Possible Risk: The main risks are the same as Open esophagectomy Procedures as surgical site complications, pulmonary complications, bleeding, Leakage, mediastinitis, fluid collection, and stenosis. Also, there is a risk of conversion from minimally invasive to open technique.
- Primary outcome parameters: The primary outcome will be the assessment of operative time, hospital stay, intraoperative and early postoperative complications, and the assessment of pathology regarding surgical margins and the retrieved lymph nodes.
- Secondary outcome parameters: The secondary outcome will be the incidence of late complications such as anastomotic stenosis and reflux symptoms and also the incidence of locoregional recurrence.
- Sample size (number of participants included) All patients with esophageal cancer who are considered candidates for esophagectomy present to NCI in the period of 2 years starting November 2022 till October 2024.
- Statistical analysis: Data will be collected in preformed data collection before being entered in the spreadsheet. Statistical analysis will be performed using the statistical package for social science (SPSS). Continuous variables will be expressed as mean and standard deviation (normally distributed data) or median and range (not normally distributed data) while categorical data expressed as numbers and percentages. Chi-square test will be used to compare the nominal data while continuous data will be compared by the student t-test (normally distributed data) and Mann-Whitney test (not normally distributed data).
- Source of funding:
Self-funding.
- Conditions
- Esophageal Cancer
- Being tested
- Minimally Invasive Surgery for Esophageal Cancer
- Keywords
- Minimally invasive, Esophageal Cancer, feasibility, outcome
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Surgery for Esophageal CancerProcedure or surgery
Assessment of minimally Invasive Surgery for Esophageal Cancer
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of Esophagectomy Esophageal Cancer | Active comparator | Minimally Invasive Surgery for Esophageal Cancer: feasibility Receives: Procedure: Minimally Invasive Surgery for Esophageal Cancer |
| Outcome of Esophagectomy Esophageal Cancer | Active comparator | Minimally Invasive Surgery for Esophageal Cancer: outcome Receives: Procedure: Minimally Invasive Surgery for Esophageal Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Operatiion
minutes
Measured: 1 day postoperative
Duration of hospital stay
Days
Measured: 2 weeks postoperative
Type of Surgical technique
Thoracoscopic, laparoscopic or combined
Measured: 1 day postoperative
Status of surgical margins
Free or not
Measured: 2 weeks postoperative
Number of lymph nodes
numbers
Measured: 2 weeks postoperative
occurence of Conversion to open
yes or no
Measured: 1 day postoperative
Amount of Blood loss
Milliliters
Measured: 1 day postoperative
Incidence of recurrence
yes or no
Measured: 6 months postoperative
Occurrence of intraoperative vascular injury
yes or no
Measured: 1 day postoperative
Occurence of anastomotic leakage
yes or no
Measured: 4 weeks postoperative
Administration of neoadjuvant therapy
yes or no
Measured: 2 weeks preoperative
Level of preoperative Haemoglobin
g/dl
Measured: 1 week preoperative
Level of postoperative Haemoglobin
g/dl
Measured: 1 week postoperative
Level of CEA preoperative
ng/ml
Measured: 2 weeks preoperative
Level of CEApostoperative
ng/ml
Measured: 4 weeks postoperative
Occurence lung injury
yes or no
Measured: 1 day postoperative
site of pathology
upper / middle or lower esophageal
Measured: 1 day preoperative
type of anastomosis
stapler or hand sewing
Measured: 1 day postoperative
Nature of gross picture of specimen
mass / ulcer
Measured: 2 weeks postoperative
Secondary outcomes (3)
Occurence of mortality
yes or no
Measured: 6 weeks postoperative
Occurence of anastomotic stenosis
yes or no
Measured: 6 weeks postoperative
Occurence of ostoperative reflux
yes or no
Measured: 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- All patients with esophageal cancer who are considered candidates for esophagectomy present to NCI in the period starting fromDecember 2022
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abd Elraheem Mohamed Kenawy, Sohag University
- Investigators
- Ahmed A Kenawy, MD, Principal investigator, Sohag UniversityAlaa-Eldin H Mohamed, professor, Study chair, Sohag UniversityAlaa A Redwan, professor, Study director, Sohag UniversityHaitham F Othman, MD, Study director, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662644
- Sponsor's protocol ID
- Soh-Med-22-11-10
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgery for Esophageal Cancer: Feasibility and Outcome
- ClinicalTrials.gov ID
- NCT05662644
- Acronym / sponsor ID
- Soh-Med-22-11-10
- Conditions
- Esophageal Cancer
- Keywords
- Minimally invasive, Esophageal Cancer, feasibility, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 22 Dec 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.
Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding
- Surgical technique: A totally minimally invasive technique (combined thoracoscopic and laparoscopic approaches) for esophagectomy will be used in this study. Also, a hybrid technique (thoracoscopic approach with laparotomy or laparoscopic approach with thoracotomy) will be included.
- Histopathology
- Assessment of surgical margins
- Assessment of the number of lymph nodes
- Peri-operative outcome including
- Operative time
- Conversion to open
- Blood loss
- Hospital stays
- Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
- Morbidity and mortality.
Detailed description
Introduction
Esophageal cancer is the seventh most common cause of cancer-related death worldwide. The overall five-year survival is below 20%.
It is characterized by its high mortality rate, poor prognosis at time of diagnosis and variability based on geographic location. Now , the prevalence of esophageal cancer is in transition .
The Arabic world has very low incidences of Esophageal cancer in general. In Egypt, it represents 1.7% of all cancers.
Esophagectomy followed by reconstruction surgery has been the most reliable modality for treatment in patients without evidence of disease spread.
Different surgical approaches, such as the Sweet esophagectomy, Ivor Lewis esophagectomy, McKeown esophagectomy, and transhiatal esophagectomy, have been used clinically based on specific locations in the esophageal cancer.
For cancer of the middle or lower segment of the thoracic esophagus, the Ivor Lewis esophagectomy and the Sweet esophagectomy through the left thoracic approach are the mainstream standard surgical approaches.
Conventional surgical treatment involves open esophagectomy (OE) using transthoracic or transhiatal approaches which are associated with high mortality and morbidity especially respiratory complications (RCs) that are common with open esophagectomy and can increase the risk of death by up to 20%.
Traditionally, an esophagectomy was performed through a right thoracotomy and laparotomy. However, these patients are at a high risk for developing postoperative pulmonary complications. In order to decrease postoperative morbidity, minimally invasive surgical techniques were introduced in the treatment of esophageal cancer.
The first thoracoscopic esophageal mobilizations for esophagectomy were performed in the early 1990s by A. Cuschieri.
Then, DePaula and colleagues and Swanström and Hansen separately published the first totally minimally invasive transhiatal esophagectomies in 1995 and 1997, respectively. Subsequently, many centers began to adapt their preferred technique to minimally invasive approaches and gained significant experience in laparoscopic and thoracoscopic approaches to esophagectomy.
Luketich et al. first identified the combined thoracoscopic esophageal mobilization followed by the laparoscopic fashioning of the gastric conduit and the development of an esophagogastric anastomosis in the cervical region.
In recent decades, minimally invasive esophagectomy (MIE) has become an alternative to open esophagectomy. minimally invasive esophagectomy (MIE) involves several techniques including total MIE (tMIE), hybrid minimally invasive esophagectomy (hMIE), and robotic surgery .
The procedure consists presently of three main techniques: combined thoracoscopic and laparoscopic approach (Ivor Lewis); thoracoscopic, laparoscopic, and cervical approach (three-hole); or laparoscopic and cervical approach only (transhiatal).
Luketich et al. subsequently published their approach to minimally invasive Ivor Lewis esophagectomy and intrathoracic anastomosis and concluded that this type of treatment is feasible.
MI McKeown esophagectomy procedure consists of thoracoscopic esophagectomy, laparoscopic gastric mobilization, and cervical anastomosis between the esophageal stump and gastric stump. With the improvement of techniques and equipment, McKeown MIE has received increased attention.
Objectives:
Evaluate the feasibility and outcome of minimally invasive management of esophageal cancer regarding
- Surgical technique: A totally minimally invasive technique (combined thoracoscopic and laparoscopic approaches) for esophagectomy will be used in this study. Also, a hybrid technique (thoracoscopic approach with laparotomy or laparoscopic approach with thoracotomy) will be included.
- Histopathology
- Assessment of surgical margins
- Assessment of the number of lymph nodes
- Peri-operative outcome including
- Operative time
- Conversion to open
- Blood loss
- Hospital stays
- Evaluation of recurrence, disease-free survival and overall survival rates: according to The Kaplan-Meier estimator
- Morbidity and mortality.
Aim of the work This study aims to evaluate the feasibility and outcome of minimally invasive management of esophageal cancer.
Study Design:
This study is going to be a prospective study where patients presenting with esophageal cancer who are considered candidates for surgery will undergo minimally invasive surgery. Each patient will be assessed in the pre, intra, and short postoperative period.
Methodology:
- Population of study \& disease Condition patients with esophageal cancer.
- Background and Demographic characteristics Any patient with esophageal cancer is considered a candidate for a minimally invasive esophagectomy procedure.
- Inclusion criteria:
- Any age.
- Any sex.
- Diagnostic operable esophageal cancer.
- Exclusion criteria:
- Metastatic patients.
- Locally advanced cases.
- Patients with comorbidities who are unfit for major surgical procedures.
- Patients with contraindications for laparoscopy or thoracoscopy.
- Interventions: Patients with esophageal cancer who are considered candidates for surgery will be subjected to minimally invasive procedures through a combined laparoscopic and thoracoscopic approach with D2 dissection and mediastinal dissection.
- Possible Risk: The main risks are the same as Open esophagectomy Procedures as surgical site complications, pulmonary complications, bleeding, Leakage, mediastinitis, fluid collection, and stenosis. Also, there is a risk of conversion from minimally invasive to open technique.
- Primary outcome parameters: The primary outcome will be the assessment of operative time, hospital stay, intraoperative and early postoperative complications, and the assessment of pathology regarding surgical margins and the retrieved lymph nodes.
- Secondary outcome parameters: The secondary outcome will be the incidence of late complications such as anastomotic stenosis and reflux symptoms and also the incidence of locoregional recurrence.
- Sample size (number of participants included) All patients with esophageal cancer who are considered candidates for esophagectomy present to NCI in the period of 2 years starting November 2022 till October 2024.
- Statistical analysis: Data will be collected in preformed data collection before being entered in the spreadsheet. Statistical analysis will be performed using the statistical package for social science (SPSS). Continuous variables will be expressed as mean and standard deviation (normally distributed data) or median and range (not normally distributed data) while categorical data expressed as numbers and percentages. Chi-square test will be used to compare the nominal data while continuous data will be compared by the student t-test (normally distributed data) and Mann-Whitney test (not normally distributed data).
- Source of funding:
Self-funding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients with esophageal cancer who are considered candidates for esophagectomy present to NCI in the period starting fromDecember 2022
| Arm | Type | Receives |
|---|---|---|
| Feasibility of Esophagectomy Esophageal Cancer | Active comparator | Procedure: Minimally Invasive Surgery for Esophageal CancerMinimally Invasive Surgery for Esophageal Cancer: feasibility |
| Outcome of Esophagectomy Esophageal Cancer | Active comparator | Procedure: Minimally Invasive Surgery for Esophageal CancerMinimally Invasive Surgery for Esophageal Cancer: outcome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Any age.
- Any sex.
- Diagnostic operable esophageal cancer.
Key exclusion criteria (4 listed)
- Metastatic patients.
- Locally advanced cases.
- Patients with comorbidities who are unfit for major surgical procedures.
- Patients with contraindications for laparoscopy or thoracoscopy.
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 |
|---|---|---|
| Minimally Invasive Surgery for Esophageal CancerAssessment of minimally Invasive Surgery for Esophageal Cancer | Procedure or surgery | Feasibility of Esophagectomy Esophageal Cancer, Outcome of Esophagectomy Esophageal Cancer |
Primary outcome
Duration of Operatiion
Time frame: 1 day postoperative
minutes
Duration of hospital stay
Time frame: 2 weeks postoperative
Days
Type of Surgical technique
Time frame: 1 day postoperative
Thoracoscopic, laparoscopic or combined
Status of surgical margins
Time frame: 2 weeks postoperative
Free or not
Number of lymph nodes
Time frame: 2 weeks postoperative
numbers
occurence of Conversion to open
Time frame: 1 day postoperative
yes or no
Amount of Blood loss
Time frame: 1 day postoperative
Milliliters
Incidence of recurrence
Time frame: 6 months postoperative
yes or no
Occurrence of intraoperative vascular injury
Time frame: 1 day postoperative
yes or no
Occurence of anastomotic leakage
Time frame: 4 weeks postoperative
yes or no
Administration of neoadjuvant therapy
Time frame: 2 weeks preoperative
yes or no
Level of preoperative Haemoglobin
Time frame: 1 week preoperative
g/dl
Level of postoperative Haemoglobin
Time frame: 1 week postoperative
g/dl
Level of CEA preoperative
Time frame: 2 weeks preoperative
ng/ml
Level of CEApostoperative
Time frame: 4 weeks postoperative
ng/ml
Occurence lung injury
Time frame: 1 day postoperative
yes or no
site of pathology
Time frame: 1 day preoperative
upper / middle or lower esophageal
type of anastomosis
Time frame: 1 day postoperative
stapler or hand sewing
Nature of gross picture of specimen
Time frame: 2 weeks postoperative
mass / ulcer
3 secondary outcomes
Occurence of mortality
Time frame: 6 weeks postoperative
Occurence of anastomotic stenosis
Time frame: 6 weeks postoperative
Occurence of ostoperative reflux
Time frame: 6 weeks postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: Undecided. Not yet decided
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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.
Ahmed A Kenawy, MD principal investigator
Sohag University
Alaa-Eldin H Mohamed, professor study chair
Sohag University
Alaa A Redwan, professor study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Surgery for Esophageal Cancer in people with Esophageal Cancer, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Dec 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Kenawy, MD candidate (1021025880 ext. +20, ahmed.qenawi@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Operatiion (time frame: 1 day postoperative). The study lists 19 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 22 Dec 2022.