JejunostomyAwake JejunostNCT07885358
Anesthesia Management and Perioperative Outcomes in Awake Jejunostomy and Gastrostomy
An observational study of Jejunostomy and Gastrostomy, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Patients requiring surgical jejunostomy or gastrostomy often have advanced malignancy, multiple comorbidities, and limited physiological reserve, which may increase the risks associated with general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jejunostomy, Gastrostomy, Anesthesia, Regional
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Oct 2026
- Phase
- Observational
- 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
Study population: Adult patients with ASA physical status III-IV who underwent open surgical jejunostomy or gastrostomy using ultrasound-guided fascial plane blocks as the planned primary anesthetic strategy at Samsun City Hospital, Türkiye, between February 2024 and August 2026. Eligible patients were identified retrospectively through hospital electronic medical records and anesthesia charts.
Who may be able to join
- Adults aged 18 years or older.
- Patients who underwent open surgical jejunostomy or gastrostomy between February 2024 and August 2026.
- American Society of Anesthesiologists (ASA) physical status III-IV.
- Use of ultrasound-guided fascial plane blocks as the planned primary anesthetic strategy.
- Availability of sufficient anesthesia records and perioperative clinical data to assess the primary outcome.
Who cannot join
- Patients younger than 18 years.
- Patients scheduled to receive general anesthesia from the outset.
- Patients undergoing endoscopic or radiologically guided jejunostomy or gastrostomy.
- Insufficient or incomplete medical records preventing assessment of the primary outcome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation of Anesthesia Management and Perioperative Outcomes in Patients Undergoing Awake Jejunostomy or Gastrostomy Under Regional Anesthesia: A Single-Center Observational Study
Patients requiring surgical jejunostomy or gastrostomy often have advanced malignancy, multiple comorbidities, and limited physiological reserve, which may increase the risks associated with general anesthesia. Ultrasound-guided fascial plane blocks may provide an alternative anesthetic approach in selected high-risk patients.
This single-center retrospective observational study aims to evaluate anesthesia management and perioperative outcomes in adult patients who underwent open surgical jejunostomy or gastrostomy using fascial plane blocks as the primary anesthetic strategy between February 2024 and August 2026.
The primary outcome is successful completion of surgery without conversion to general anesthesia. Secondary outcomes include supplementary sedative and analgesic requirements, airway interventions, intraoperative adverse events, postoperative rescue analgesia, length of hospital stay, and in-hospital mortality.
Read the detailed description
Surgical jejunostomy and gastrostomy are important procedures for establishing enteral nutritional access in patients who cannot maintain adequate oral intake. Patients requiring these procedures frequently have advanced malignancies, malnutrition, reduced physiological reserve, and significant cardiopulmonary comorbidities. General anesthesia may be associated with additional perioperative challenges in this high-risk population, particularly regarding hemodynamic stability, airway management, and postoperative respiratory function.
Ultrasound-guided fascial plane blocks have emerged as regional anesthetic techniques that may provide adequate somatic analgesia for selected abdominal surgical procedures. Techniques such as rectus sheath block (RSB), recto-intercostal fascial plane block (RIFPB), serratus-intercostal plane block (SIPB), and thoracoabdominal nerves block through the perichondrial approach (TAPA) can be applied individually or in combination according to the surgical incision and anticipated sensory distribution. As these techniques primarily target somatic innervation, supplementary intravenous sedation and analgesia may be required during visceral manipulation.
This study is designed as a single-center, retrospective, observational case series conducted at Samsun City Hospital, Türkiye. Medical records of 16 adult patients with American Society of Anesthesiologists (ASA) physical status III-IV who underwent open surgical jejunostomy or gastrostomy between February 2024 and August 2026 were retrospectively evaluated.
All included patients had a documented plan to use ultrasound-guided fascial plane blocks as the primary anesthetic strategy. Block selection and combinations were individualized according to the planned surgical incision and the clinical condition of each patient. Intravenous sedative and analgesic medications were administered when clinically indicated.
Demographic characteristics, comorbidities, ASA physical status, surgical indications, regional anesthesia techniques, local anesthetic administration, supplementary sedative and analgesic requirements, and respiratory support were extracted from hospital records and anesthesia charts.
The primary outcome was completion of the planned surgical procedure without conversion to general anesthesia. Secondary outcomes included intraoperative supplementary medication requirements, new airway interventions, hypotension, bradycardia, oxygen desaturation, vasopressor requirements, postoperative rescue analgesia, documented early complications, postoperative hospital length of stay, and in-hospital mortality.
Data were evaluated using descriptive statistical methods. Continuous variables were summarized using medians and interquartile ranges, while categorical variables were expressed as frequencies and percentages. Exact binomial 95% confidence intervals were calculated for selected outcomes.
The study aims to describe the clinical feasibility and perioperative characteristics of individualized fascial plane block-based anesthesia in high-risk patients requiring surgical enteral access. Because of its retrospective, uncontrolled design, the study is not intended to establish comparative effectiveness or safety.
- Conditions
- Jejunostomy, Gastrostomy, Anesthesia, Regional
- Keywords
- Regional anesthesia, Fascial plane block, Recto-intercostal fascial plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fascial Plane Block-Based Anesthesia Group | Adult patients with American Society of Anesthesiologists (ASA) physical status III-IV who underwent open surgical jejunostomy or gastrostomy using ultrasound-guided fascial plane blocks as the primary anesthetic strategy between February 2024 and August 2026. Regional anesthesia techniques included rectus sheath block (RSB), recto-intercostal fascial plane block (RIFPB), serratus-intercostal plane block (SIPB), and thoracoabdominal nerves block through the perichondrial approach (TAPA), administered individually or in combination according to clinical requirements. Intravenous sedation and analgesia were provided when clinically indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Surgery Without Conversion to General Anesthesia
The proportion of patients in whom the planned surgical jejunostomy or gastrostomy was completed using a fascial plane block-based anesthetic strategy, with supplementary sedation or analgesia as clinically indicated, without conversion to general anesthesia. Conversion status was determined from the anesthesia records. The outcome was expressed as the number and percentage of patients, with an exact binomial 95% confidence interval.
Measured: "Perioperative/Periprocedural"
Secondary outcomes (8)
Supplementary Sedative and Analgesic Requirements
The number and percentage of patients receiving supplementary intravenous sedative or analgesic medications during surgery, including midazolam, ketamine, propofol, and fentanyl, as documented in anesthesia records.
Measured: "Perioperative/Periprocedural"
New Airway Intervention
The number and percentage of patients requiring a new airway intervention during surgery. Continuation of pre-existing mechanical ventilation through a tracheostomy was not classified as a new airway intervention.
Measured: "Perioperative/Periprocedural"
Intraoperative Adverse Events
The number and percentage of patients with documented intraoperative hypotension, bradycardia, or oxygen desaturation, based on retrospective anesthesia records. Standardized numerical thresholds were not established in the available study description.
Measured: "Perioperative/Periprocedural"
Intraoperative Vasopressor Requirement
The number and percentage of patients receiving vasopressor medication during the surgical procedure, as documented in anesthesia records.
Measured: "Perioperative/Periprocedural"
Postoperative Rescue Analgesic Requirement
The number and percentage of patients with documented administration of additional postoperative analgesics beyond routine intravenous paracetamol.
Measured: postoperative 24 hours
Documented Early Postoperative Complications
The number and percentage of patients with early block-related or procedure-related complications documented in the reviewed hospital records.
Measured: postoperative 24 hours
Postoperative Length of Hospital Stay
The number of days from the surgical procedure to hospital discharge among patients discharged alive, summarized using the median and interquartile range.
Measured: up to two months
In-Hospital Mortality
The number and percentage of patients who died during the index hospitalization following surgical jejunostomy or gastrostomy. Deaths documented within 30 days of surgery were also described. Complete 30-day all-cause mortality was not assessed.
Measured: up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Feb 2024
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JejunostomyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Ertas, Samsun University
- Investigators
- Gamze Ertaş, md, Principal investigator, samsun univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885358
- Sponsor's protocol ID
- awake-jg
- Acronym
- Awake Jejunost
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to patient confidentiality and institutional data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Anesthesia Management and Perioperative Outcomes in Patients Undergoing Awake Jejunostomy or Gastrostomy Under Regional Anesthesia: A Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT07885358
- Acronym / sponsor ID
- Awake Jejunost / awake-jg
- Conditions
- Jejunostomy, Gastrostomy, Anesthesia, Regional
- Keywords
- Regional anesthesia, Fascial plane block, Recto-intercostal fascial plane block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 21 Oct 2026 (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.
Patients requiring surgical jejunostomy or gastrostomy often have advanced malignancy, multiple comorbidities, and limited physiological reserve, which may increase the risks associated with general anesthesia. Ultrasound-guided fascial plane blocks may provide an alternative anesthetic approach in selected high-risk patients.
This single-center retrospective observational study aims to evaluate anesthesia management and perioperative outcomes in adult patients who underwent open surgical jejunostomy or gastrostomy using fascial plane blocks as the primary anesthetic strategy between February 2024 and August 2026.
The primary outcome is successful completion of surgery without conversion to general anesthesia. Secondary outcomes include supplementary sedative and analgesic requirements, airway interventions, intraoperative adverse events, postoperative rescue analgesia, length of hospital stay, and in-hospital mortality.
Detailed description
Surgical jejunostomy and gastrostomy are important procedures for establishing enteral nutritional access in patients who cannot maintain adequate oral intake. Patients requiring these procedures frequently have advanced malignancies, malnutrition, reduced physiological reserve, and significant cardiopulmonary comorbidities. General anesthesia may be associated with additional perioperative challenges in this high-risk population, particularly regarding hemodynamic stability, airway management, and postoperative respiratory function.
Ultrasound-guided fascial plane blocks have emerged as regional anesthetic techniques that may provide adequate somatic analgesia for selected abdominal surgical procedures. Techniques such as rectus sheath block (RSB), recto-intercostal fascial plane block (RIFPB), serratus-intercostal plane block (SIPB), and thoracoabdominal nerves block through the perichondrial approach (TAPA) can be applied individually or in combination according to the surgical incision and anticipated sensory distribution. As these techniques primarily target somatic innervation, supplementary intravenous sedation and analgesia may be required during visceral manipulation.
This study is designed as a single-center, retrospective, observational case series conducted at Samsun City Hospital, Türkiye. Medical records of 16 adult patients with American Society of Anesthesiologists (ASA) physical status III-IV who underwent open surgical jejunostomy or gastrostomy between February 2024 and August 2026 were retrospectively evaluated.
All included patients had a documented plan to use ultrasound-guided fascial plane blocks as the primary anesthetic strategy. Block selection and combinations were individualized according to the planned surgical incision and the clinical condition of each patient. Intravenous sedative and analgesic medications were administered when clinically indicated.
Demographic characteristics, comorbidities, ASA physical status, surgical indications, regional anesthesia techniques, local anesthetic administration, supplementary sedative and analgesic requirements, and respiratory support were extracted from hospital records and anesthesia charts.
The primary outcome was completion of the planned surgical procedure without conversion to general anesthesia. Secondary outcomes included intraoperative supplementary medication requirements, new airway interventions, hypotension, bradycardia, oxygen desaturation, vasopressor requirements, postoperative rescue analgesia, documented early complications, postoperative hospital length of stay, and in-hospital mortality.
Data were evaluated using descriptive statistical methods. Continuous variables were summarized using medians and interquartile ranges, while categorical variables were expressed as frequencies and percentages. Exact binomial 95% confidence intervals were calculated for selected outcomes.
The study aims to describe the clinical feasibility and perioperative characteristics of individualized fascial plane block-based anesthesia in high-risk patients requiring surgical enteral access. Because of its retrospective, uncontrolled design, the study is not intended to establish comparative effectiveness or safety.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fascial Plane Block-Based Anesthesia Group | – | –Adult patients with American Society of Anesthesiologists (ASA) physical status III-IV who underwent open surgical jejunostomy or gastrostomy using ultrasound-guided fascial plane blocks as the primary anesthetic strategy between February 2024 and August 2026. Regional anesthesia techniques included rectus sheath block (RSB), recto-intercostal fascial plane block (RIFPB), serratus-intercostal plane block (SIPB), and thoracoabdominal nerves block through the perichondrial approach (TAPA), administered individually or in combination according to clinical requirements. Intravenous sedation and analgesia were provided when clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ASA physical status III-IV who underwent open surgical jejunostomy or gastrostomy using ultrasound-guided fascial plane blocks as the planned primary anesthetic strategy at Samsun City Hospital, Türkiye, between February 2024 and August 2026. Eligible patients were identified retrospectively through hospital electronic medical records and anesthesia charts.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Patients who underwent open surgical jejunostomy or gastrostomy between February 2024 and August 2026.
- American Society of Anesthesiologists (ASA) physical status III-IV.
- Use of ultrasound-guided fascial plane blocks as the planned primary anesthetic strategy.
- Availability of sufficient anesthesia records and perioperative clinical data to assess the primary outcome.
Key exclusion criteria (4 listed)
- Patients younger than 18 years.
- Patients scheduled to receive general anesthesia from the outset.
- Patients undergoing endoscopic or radiologically guided jejunostomy or gastrostomy.
- Insufficient or incomplete medical records preventing assessment of the primary outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion of Surgery Without Conversion to General Anesthesia
Time frame: "Perioperative/Periprocedural"
The proportion of patients in whom the planned surgical jejunostomy or gastrostomy was completed using a fascial plane block-based anesthetic strategy, with supplementary sedation or analgesia as clinically indicated, without conversion to general anesthesia. Conversion status was determined from the anesthesia records. The outcome was expressed as the number and percentage of patients, with an exact binomial 95% confidence interval.
8 secondary outcomes
Supplementary Sedative and Analgesic Requirements
Time frame: "Perioperative/Periprocedural"
New Airway Intervention
Time frame: "Perioperative/Periprocedural"
Intraoperative Adverse Events
Time frame: "Perioperative/Periprocedural"
Intraoperative Vasopressor Requirement
Time frame: "Perioperative/Periprocedural"
Postoperative Rescue Analgesic Requirement
Time frame: postoperative 24 hours
Documented Early Postoperative Complications
Time frame: postoperative 24 hours
Postoperative Length of Hospital Stay
Time frame: up to two months
In-Hospital Mortality
Time frame: up to two months
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 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to patient confidentiality and institutional data protection requirements.
Related trials for Jejunostomy
RecruitingObservational study
Evaluation of the Administration of Artificial Nutrition by Feeding Jejunostomy During Neoadjuvant Treatment on Postoperative Morbidity in the Context of Esophageal or Stomach Cancer
Esophageal Cancer, Surgery Indication
Active, not recruitingObservational study
Effect of Feeding Jejunostomy on Sarcopenia in Patients With Esophageal Cancer
Esophageal Cancer, Esophageal Carcinoma
RecruitingObservational study
Prospective Registry Of Therapeutic EndoscopiC ulTrasound
Gastric Outlet Obstruction, Biliary Obstruction
Recruiting
Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
Gastrostomy
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.
Gamze Ertaş, md principal investigator
samsun univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jejunostomy and Gastrostomy, run by Samsun University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 21 Oct 2026. 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 Turkey (Türkiye). 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 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?
Completion of Surgery Without Conversion to General Anesthesia (time frame: "Perioperative/Periprocedural"). 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 21 Oct 2026.